ACUSNARE POLYPECTOMY SNARE SOFT
Report
- Report Number
- 1037905-2024-00203
- Event Type
- Malfunction
- Date Received
- April 8, 2024
- Date of Event
- March 15, 2024
- Report Date
- April 8, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- FDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUED: SECTION G: 510K: K173673. INVESTIGATION EVALUATION: THE PRODUCTS SAID TO BE INVOLVED WERE RETURNED IN A BIOHAZARD BAG WITH TWO SMALLER BIOHAZARD BAGS INSIDE. NO LOT NUMBER WAS RETURNED WITH THE DEVICES. DEVICE #1: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE RETURNED WITH THE SNARE HEAD FULLY RETRACTED INTO THE SHEATH. A VISUAL INSPECTION IDENTIFIED KINKING FROM THE PROXIMAL END OF THE HANDLE TO 1.9CM. THE DEVICE WAS FUNCTION TESTED AND THE SNARE ADVANCED/RETRACTED WHEN THE HANDLE WAS MANIPULATED WITH SOME RESISTANCE. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. DEVICE #2: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE RETURNED WITH THE SNARE HEAD FULLY RETRACTED INTO THE SHEATH. A VISUAL INSPECTION IDENTIFIED KINKING FROM THE PROXIMAL END OF THE HANDLE TO 3.0CM. THE DEVICE WAS FUNCTION TESTED AND THE SNARE ADVANCED/RETRACTED WHEN THE HANDLE WAS MANIPULATED WITH SIGNIFICANT RESISTANCE. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE HISTORY RECORDS FOR THE LOT NUMBERS SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE RETURNED DEVICES CONFIRMED THE REPORT. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.
DURING A COLONOSCOPY WITH POLYPECTOMY, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE, SOFT. IT WAS REPORTED THAT THE POLYP STALK WAS VERY HARD, AND THEY WERE UNABLE TO CUT THRU THE STALK. SEVERAL SNARES WERE USED AS THEY STATED THEY THOUGHT THE SNARE WAS MELTING THE PLASTIC SHEATH AT THE BASE OF THE HANDLE BUT IT WAS DETERMINED THAT IT WAS NOT MELTING BUT KINKING DUE TO THE TENSION PLACED ON THE HANDLE AND THE WIRE NOT CUTTING THRU THE POLYP STALK. THEY WERE ABLE TO SUCCESSFULLY REMOVE THE POLYP WITH ANOTHER OF THE SAME DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143812 | ACUSNARE POLYPECTOMY SNARE SOFT | FDI, SNARE, FLEXIBLE | FDI | WILSON-COOK MEDICAL INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ENDOSCOPE - UNKNOWN MAKE OR MODEL |