LESIONHUNTER(TM) ROTATABLE NITINOL COLD SNARE

Additional Manufacturer Narrative

THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. HOWEVER, THE INCIDENT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE INCIDENT INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT FLEXIBLE SNARE TIP BROKE OFF INSIDE PATIENT'S COLON DURING ATTEMPT TO USE DEVICE TO REMOVE A POLYP BY PHYSICIAN AND SURGICAL TECH. SNARE TIP NOT RETRIEVED, NO DETECTABLE HARM TO PATIENT. LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM LOT M240815304, EXP: 08/14/2029, DATE OF MANUFACTURE: 08-15-2024 REF: (B)(4).

Additional Manufacturer Narrative

1. INCIDENT DESCRIPTION: IT WAS REPORTED THAT FLEXIBLE SNARE TIP BROKE OFF INSIDE PATIENT'S COLON DURING ATTEMPT TO USE DEVICE TO REMOVE A POLYP BY PHYSICIAN AND SURGICAL TECH. SNARE TIP NOT RETRIEVED, NO DETECTABLE HARM TO PATIENT. LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM LOT M240815304, EXP: 08/14/2029, DATE OF MANUFACTURE: 08-15-2024 REF: (B)(4). 2.EXTERNAL INVESTIGATION: ON (B)(6) 2025, MICRO-TECH HAS COMMUNICATED WITH THE CUSTOMER TO SEE IF THERE IS ANY OTHER CLINICAL USAGE INFORMATION. ON (B)(6) 2025, THE CUSTOMER REPLIED THAT THERE WERE NO PHOTOS OR VIDEOS, AND A SINGLE WIRE BREAK OCCURRED AT THE SURGICAL SITE COLON, WERE 6 POLYPS REMOVED FROM SIGMOID, TRANSVERSE, ASCENDING COLON, AND CECUM THAT WERE REMOVED VIA COLD SNARE. AT THE SAME TIME, MICRO-TECH WILL CONDUCT AN INTERNAL INVESTIGATION AND ANALYSIS. 3.INTERNAL INVESTIGATIONS: ACCORDING TO CUSTOMER COMPLAINT FEEDBACK INFORMATION, COMBINED WITH HISTORICAL CUSTOMER COMPLAINT AND PRODUCT STRUCTURE, WE INVESTIGATE THE INTENDED USE, RAW MATERIALS, PRODUCTION PROCESS, APPLICABLE INSTRUCTIONS AND STORAGE, AND THE SPECIFIC INVESTIGATION INFORMATION IS AS FOLLOWS: 3.1 INTENDED USE THE COLD SNARE IS INDICATED FOR USE ENDOSCOPICALLY FOR THE REMOVAL OF DIMINUTIVE POLYPS, SESSILE POLYPS, PEDUNCULATED POLYPS AND TISSUE FROM WITHIN THE GASTROINTESTINAL TRACT. ANALYSIS: THE DESCRIPTION OF INTENDED USE IS CLEAR AND CLEAR, AND THERE WILL BE NO AMBIGUITY IN "REMOVING SMALL POLYPS, NON STULTIFORM POLYPS, AND STULTIFORM POLYPS AND TISSUES FROM GASTROINTESTINAL TRACT". ACCORDING TO STATISTICS, THIS TYPE OF COMPLAINT OF OCCURRENCE IS VERY LOW, SO WE CAN BE SURE THAT THE INTENDED USE OF COLD SNARE CAN MEET CLINICAL REQUIREMENTS. 3.2 RAW MATERIAL RAW MATERIALS: COLD SNARE CONSISTS OF LOOP, OUTER TUBE, MANDREL, SLIDER, ETC. RAW MATERIALS SHALL BE PUT INTO STORAGE AFTER THEIR MATERIALS, APPEARANCE AND DIMENSION ARE QUALIFIED. IF RIVETING TOOLING FAILS, IT WILL RESULT IN POOR BATCH SIZE. THIS PROCESS IS COMPLETED BY THE SUPPLIER. IQC WILL RANDOMLY DRAW THE RAW MATERIALS AT THE TIME OF INCOMING MATERIALS. 3.3 PRODUCTION PROCESS THE PRODUCTION PROCESS: THE FIRST AND LAST INSPECTION OF RIVETING TENSION, IPQC INSPECTION, FINISHED INSPECTION AND DELIVERY INSPECTION WERE ALL QUALIFIED. THEREFORE, THE FAILURE OF RIVETING TOOLING CAUSED BY UNQUALIFIED TENSION CAUSED BY SNARE FALLING OFF WAS EXCLUDED. 3.4 INSTRUCTIONS FOR USE 3.4.1. RETRACT THE HANDLE OF THE SNARE AND CONFIRM THAT THE SNARE LOOP IS FULLY RETRACTED INTO THE CATHETER PRIOR TO INSERTING THE CATHETER INTO THE ENDOSCOPE. 3.4.2. SLOWLY ADVANCE THE CATHETER THROUGH THE ENDOSCOPE CHANNEL UNTIL THE TIP APPEARS IN THE ENDOSCOPIC VIEW AND THE LESION IS CLEARLY IDENTIFIED AND TARGETED. 3.4.3. OPERATE THE HANDLE TO EXTEND THE SNARE LOOP AND GENTLY SNARE THE TARGET TISSUE. NOTE: THE SNARE LOOP CAN BE ROTATED IF DESIRED BY HOLDING THE OUTER SHEATH ASSEMBLY AND ROTATING THE HANDLE. 3.4.4. CONFIRM APPROPRIATE TISSUE IS CAPTURED AND PROCEED TO RESECT BY GENTLY PULLING THE SLIDER. 3.4.5. REPEAT STEPS 3&4. RETRACT THE SNARE PRIOR TO REMOVING THE INSTRUMENT FROM THE ENDOSCOPE. ANALYSIS: THE INSTRUCTION MANUAL CLARIFIES THE METHOD OF USE: " OPERATE THE HANDLE TO EXTEND THE SNARE LOOP AND GENTLY SNARE THE TARGET TISSUE ". THE DESCRIPTION IS CLEAR AND CLEAR, AND THERE WILL BE NO AMBIGUITY, SO WE CAN CONFIRM THIS CUSTOMER COMPLAINT IT HAS NOTHING TO DO WITH THE METHOD OF USE DESCRIBED IN THE MANUAL. 3.5 STORAGE WE HAVE SPECIFIC REQUIREMENTS FOR THE STORAGE OF COLD SNARE PRODUCTS: THE PRODUCT SHOULD BE STORED IN A COOL, DRY, CLEAN, WELL-VENTILATED, NON-CORROSIVE GAS ENVIRONMENT. DO NOT EXPOSE THE PACKAGE TO ORGANIC SOLVENT, IONIZING RADIATION OR ULTRAVIOLET RADIATION. ANALYSIS: THE VALIDITY PERIOD OF THE COLD SNARE WAS CONFIRMED IN DETAIL IN THE DESIGN AND DEVELOPMENT STAGE, AND THE COLD SNARE WAS CONFIRMED TO BE SAFE AND EFFECTIVE IN THE VALIDITY PERIOD. MORE DETAILED STORAGE CONDITIONS ARE ALSO DETAILED IN THE MANUAL. THEREFORE, WE CAN CONFIRM THAT THIS COLD SNARE CUSTOMER COMPLAINT HAS NOTHING TO DO WITH STORAGE. DHR REVIEW: WE HAVE REVIEWED THE DHR RECORDS FOR THIS LOT (M240815304) AND FOUND NO ABNORMALITY. CONCLUSION: AFTER CHECKING THE EXPECTED USE, RAW MATERIALS, PRODUCTION PROCESS, APPLICATION INSTRUCTIONS AND STORAGE OF THE COLD SNARE, THEY ALL MEET THE STANDARD REQUIREMENTS, THEREFORE, THE ROOT CAUSE OF THE COLD SNARE FRACTURE HAS NOT BEEN FOUND. WE WILL CONTINUE TO PAY ATTENTION TO IT.