ACUSNARE POLYPECTOMY SNARE
Report
- Report Number
- 1037905-2024-00413
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- June 20, 2024
- Report Date
- August 30, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- FDI
- UDI-DI
- 00827002226302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
SECTION G: PMA/510(K): K173673 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE REPORT OF INABILITY TO CUT AND CAPTURE THE POLYP IS LIKELY DUE TO THE ADVANCEMENT AND RETRACTION DIFFICULTY NOTED BY THE USER. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE." ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES "FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS FOR SETTINGS, VERIFY THE DESIRED SETTINGS AND ACTIVATE THE ELECTROSURGICAL UNIT SECURELY CONNECT THE ACTIVE CORD TO THE DEVICE HANDLE AND ELECTROSURGICAL USE PROCEED WITH THE POLYPECTOMY, UPON COMPLETION OF THE POLYPECTOMY, TURN THE ELECTROSURGICAL UNIT OFF." 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.
INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A WHITE PLASTIC BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE SNARE RETRACTED INTO THE SHEATH. THE DEVICE WOULD ADVANCE AND RETRACT WITH NO RESISTANCE WHEN THE HANDLE WAS MANIPULATED. THE DEVICE WAS THEN ADVANCED DOWN AN ENDOSCOPE THAT HAS AN ACCESSORY CHANNEL THAT IS 2.8 MM IN DIAMETER (OLYMPUS 2.8 GIF Q20 ENDOSCOPE). THE TIP OF THE SCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. THE SNARE WAS DIFFICULT TO ADVANCE, HOWEVER THERE WAS NO RETRACTION DIFFICULTY. THE CONTINUITY FROM THE ELECTRICAL PIN TO THE SNARE HEAD WAS TESTED WITH AN OHM METER AND PASSED. AN ADDITIONAL FUNCTIONAL TEST WITH THE DEVICE WAS PERFORMED BY ATTACHING THE ACTIVE CORD TO THE ELECTRICAL PIN. THE ACTIVE CORD CONNECTED TO THE DEVICE EASILY AND REMAINED SECURELY CONNECTED. THE DEVICE WAS CONNECTED TO A VALLEY LAB GENERATOR AND POWER WAS APPLIED. THE SNARE CUT AND COAGULATED SIMULATED TISSUE AS EXPECTED.. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE ADVANCEMENT/RETRACTION DIFFICULTY IS LIKELY WHAT LEAD TO THE USER'S REPORT OF INABILITY TO CUT AND CAPTURE THE POLYP. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE." ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES "FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS FOR SETTINGS, VERIFY THE DESIRED SETTINGS AND ACTIVATE THE ELECTROSURGICAL UNIT....SECURELY CONNECT THE ACTIVE CORD TO THE DEVICE HANDLE AND ELECTROSURGICAL USE....PROCEED WITH THE POLYPECTOMY, UPON COMPLETION OF THE POLYPECTOMY, TURN THE ELECTROSURGICAL UNIT OFF." 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 AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. IT WAS REPORTED [THAT IT WAS] NOT EASY TO CAPTURE THE POLYP. ADVANCEMENT AND RETRACTION OF SNARE WAS NOT VERY SMOOTH [DIFFICULT TO RETRACT]. 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 |
|---|---|---|---|---|---|---|---|
| 922566 | ACUSNARE POLYPECTOMY SNARE | FDI, SNARE, FLEXIBLE | FDI | WILSON-COOK MEDICAL INC | W4752146 | 00827002226302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | ERBE2000 GENERATOR| OLYMPUS 290 GASTROSCOPE |