LESIONHUNTER(TM) ROTATABLE NITINOL COLD SNARE

Additional Manufacturer Narrative

THIS IS THE SECOND REPORT. ANOTHER MFR REPORT#: 3004837686-2025-00001. 1. INCIDENT DESCRIPTION: DEVICE BROKE WHILE USING DURING A PROCEDURE - SECOND DEVICE OF THE SAME LOT NUMBER WAS DEPLOYED AND ALSO BROKE IN THE SAME FASHION. 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 PICTURES OR VIDEOS AVAILABLE, POLYP WAS SMALL, AND BOTH TIMES, THE WIRE BECAME COMPLETELY DETACHED FROM THE CATHETER. AT THE SAME TIME, MICRO-TECH WILL CONDUCT 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, INSTRUCTIONS FOR USE 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. AFTER INQUIRY, THE BATCH NUMBER OF ORIGINAL MATERIALS OF LOOP CORRESPONDING TO THIS BATCH ARE 20240507J22-I001 AND 20240204J05-I011. THIS BATCHES OF TENSILE FORCE TEST IS OK. 3.3 PRODUCTION PROCESS: ACCORDING TO THE BATCH NUMBER PROVIDED BY THE CUSTOMER, WE CHECKED DHR AND FOUND THAT THE BATCH NUMBER OF THIS BATCH OF FINISHED PRODUCTS CORRESPONDED TO 1 BATCH OF SNARE ASSEMBLY. 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. CONCLUSION: AFTER CHECKING THE INTENDED USE, RAW MATERIALS, PRODUCTION PROCESS, INSTRUCTIONS FOR USE AND STORAGE OF THE COLD SNARE, THEY ALL MEET THE STANDARD REQUIREMENTS, AND NO BAD SAMPLES HAVE BEEN RECEIVED, AND NO MORE RELEVANT INFORMATION CAN BE FURTHER ANALYZED. THEREFORE, THE ROOT CAUSE OF THE COLD SNARE FRACTURE HAS NOT BEEN FOUND. WE WILL CONTINUE TO PAY ATTENTION TO IT.

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

ON JANUARY 3, 2025. MICRO-TECH RECEIVED 2 REPORTS REGARDING COLD SNARE OF MICRO-TECH(NANJING) CO., LTD. MEDWATCH REPORT #: MW5163519.THIS IS THE SECOND REPORT. IT WAS REPORTED THAT "DEVICE BROKE WHILE USING DURING A PROCEDURE- SECOND DEVICE OF THE SAME LOT NUMBER WAS DEPLOYED AND ALSO BROKE IN THE SAME FASHION. BOTH DEVICES WERE THE LESION HUNTER REF NUMBER: CS2-21523231, LOT NUMBER: M240417302. REFERENCE REPORT: MW 5163518. "