Specifications
| Model | Working Length (mm) | Min. Working Channel (mm) | Jaw O.D. (mm) | Jaw Shape | Jaw Tip | Rotatable (Y/N) | Standard Color |
|---|---|---|---|---|---|---|---|
| 01 Series | 2300 | 2.8 | 2.3 | Alligator | / | N | Blue |
| 02 Series | 2300 | 2.0 | 1.8 | / | Rat teeth | N | Blue |
| 03 Series | 2300 | 2.8 | 2.3 | Alligator | Rat teeth | N | Blue |
| 03 Series | 2300 | 2.8 | 2.3 | Alligator | Rat teeth | N | Blue |
| 09 Series | 1600 | 2.8 | 2.3 | Alligator | Rat teeth | Y | Blue |
| 09 Series | 2300 | 2.8 | 2.3 | Alligator | Rat teeth | Y | Blue |
| 10 Series | 1600 | 2.8 | 2.3 | Alligator | Rat teeth | N | Blue |
| 10 Series | 2300 | 2.8 | 2.3 | Alligator | Rat teeth | N | Blue |
Instructions for Use
Intended Use
The KINDMED™ Foreign Body Grasping Forceps are intended for endoscopic grasping, retrieval, and removal of foreign bodies, tissue fragments, food boluses, and other suitable materials from the gastrointestinal tract.
The device is designed to provide secure capture and controlled extraction during diagnostic and therapeutic endoscopic procedures.
The device is supplied sterile and intended for single-patient use only.
Device Description
The KINDMED™ Foreign Body Grasping Forceps are flexible endoscopic retrieval instruments designed for controlled grasping and removal of foreign objects and tissue within the gastrointestinal tract.
The device consists of:
- Control handle
- Slider mechanism
- Flexible catheter
- Distal grasping jaws
The proximal slider controls opening and closing of the distal jaws through an internal actuation mechanism. The jaws feature a hybrid alligator-tooth and rat-tooth configuration designed to provide enhanced gripping performance and secure retention of retrieved objects.
The handle incorporates a 360° rotational mechanism, allowing precise orientation and positioning of the jaws during endoscopic procedures.
The device is compatible with appropriately sized endoscope working channels according to the product specifications.
Contraindications
The device should not be used in the following situations:
- Patients with significant coagulation disorders.
- Clinical conditions where endoscopy is contraindicated.
- Situations where foreign body retrieval presents unacceptable procedural risk.
- Procedures involving electrosurgical activation of the forceps.
- Cases where device use may compromise patient safety as determined by the treating physician.
Patient suitability should be evaluated based on clinical assessment and procedural requirements.
Potential Adverse Events
Potential complications associated with foreign body retrieval procedures may include:
- Bleeding or hemorrhage
- Perforation
- Mucosal injury
- Infection
- Sepsis
- Fever
- Aspiration
- Hypotension
- Respiratory depression
- Respiratory arrest
- Cardiac arrhythmias
- Cardiac arrest
- Allergic reactions to medications or contrast agents
The occurrence and severity of complications may vary depending on patient condition, object characteristics, and procedural complexity.
Warnings
- Read all instructions carefully before use.
- The device is intended for single use only.
- Do not reuse, reprocess, or resterilize.
- Reuse may result in contamination, infection, device malfunction, or patient injury.
- Do not use after the expiration date indicated on the package.
- Inspect all components before use.
- Do not use damaged, defective, or deformed devices.
- Use the device only for its intended purpose.
- Excessive force during insertion or retrieval may damage the device, endoscope, or patient tissue.
- Foreign body retrieval should be performed under direct endoscopic visualization.
- Maintain secure grasping during withdrawal to prevent accidental release or aspiration of the retrieved object.
- Do not insert the device when endoscopic visualization is inadequate.
- Do not introduce the forceps through the endoscope while the jaws are in the open position.
- Dispose of used devices in accordance with hospital and regulatory requirements.
Precautions
- Verify compatibility between the device and the endoscope working channel before use.
- Use only by physicians trained in gastrointestinal endoscopy and foreign body retrieval techniques.
- Maintain the jaws in a closed position during insertion and withdrawal through the endoscope channel.
- Avoid excessive manipulation, torque, bending, or force.
- Apply only the amount of gripping force required to secure the target object.
- Monitor device performance continuously during the procedure.
- Use caution when retrieving large, fragile, or irregularly shaped objects.
Instructions for Use
Preparation
- Verify package integrity and expiration date.
- Open the sterile package using aseptic technique.
- Remove the device carefully and inspect for bends, kinks, damage, or loose components.
- Operate the slider several times to confirm smooth opening and closing of the jaws.
- Ensure compatibility with the selected endoscope.
Device Placement
- Insert the forceps through the endoscope working channel while maintaining the jaws in the closed position.
- Advance the device under direct endoscopic visualization until the distal jaws are visible.
- Position the jaws adjacent to the target object or tissue.
Object Capture
- Open the jaws using the slider mechanism.
- Advance the jaws carefully toward the target.
- Close the jaws gently to secure the object.
- Confirm adequate grasping before retrieval.
- Avoid excessive closing force that may damage the object or device.
Retrieval Procedure
- Maintain secure closure of the jaws throughout withdrawal.
- Withdraw the object together with the endoscope when clinically appropriate.
- Do not retract the captured object into the endoscope working channel.
- Once removed from the patient, open the jaws and release the retrieved material.
- Repeat the procedure if additional retrieval is required.
Device Removal
- Confirm the jaws are fully closed.
- Withdraw the device carefully from the endoscope.
- Inspect the device following use.
- Dispose of the device according to applicable regulations.
Change in Performance
If the device exhibits altered functionality, reduced gripping capability, impaired jaw movement, rotational malfunction, or inability to perform its intended purpose, discontinue use immediately.
Further patient management should be determined by the treating physician according to clinical circumstances.
Storage Conditions
Store in a clean, dry, and well-ventilated environment.
Protect from:
- Direct sunlight
- Excessive heat
- Moisture
- Organic solvents
- Ionizing radiation
- Ultraviolet radiation
- Corrosive environments
Observe stock rotation procedures and do not use beyond the expiration date.
Disposal
Following use, the device should be treated as potentially biohazardous waste and disposed of in accordance with hospital, local, state, and national regulations.
Limited Warranty
KINDMED DEVICES PRIVATE LIMITED warrants that this product has been manufactured in accordance with established quality management procedures and applicable manufacturing standards.
Because storage conditions, transportation, handling practices, procedural techniques, patient-specific factors, and other variables are beyond the manufacturer’s control, no guarantee is made regarding clinical outcomes.
The manufacturer’s liability is limited to replacement of defective products. KINDMED DEVICES PRIVATE LIMITED shall not be liable for incidental, indirect, special, or consequential damages arising from misuse, modification, reprocessing, resterilization, or reuse of the device.
Manufacturer
KINDMED DEVICES PRIVATE LIMITED
1st Floor, Plot No. 175B
Dada Nagar Industrial Area
Kanpur Nagar, Uttar Pradesh – 208022, India
KINDMED™ is a trademark of KINDMED DEVICES PRIVATE LIMITED.
