INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
Report
- Report Number
- 1037905-2024-00131
- Event Type
- Malfunction
- Date Received
- March 6, 2024
- Date of Event
- February 8, 2024
- Report Date
- March 27, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- PKL
- UDI-DI
- 00827002580107
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITH 30 DAYS OF SUBMISSION OF THIS REPORT.
510(K): K212323. 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. HOWEVER, TWO EMPTY POUCHES FROM THE POSSIBLE LOT NUMBERS PROVIDED IN THE REPORT WERE RETURNED. THE DEVICE HISTORY RECORDS FOR THE POSSIBLE LOT NUMBERS SAID TO BE INVOLVED WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: 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 INCLUDE THE FOLLOWING: "UNCOIL DEVICE. VERIFY SMOOTH HANDLE OPERATION AND CLIP ACTION. OPEN CLIP BY GENTLY MOVING HANDLE SPOOL DISTALLY (AWAY FROM HANDLE THUMB RING). ONCE CLIP IS FULLY OPEN, DO NOT CONTINUE ADVANCING HANDLE SPOOL AS CLIP MAY PREMATURELY DETACH FROM CATHETER. CLOSE CLIP BY MOVING HANDLE SPOOL PROXIMALLY UNTIL CLIP IS FULLY CLOSED." IFU ALSO CONTAINS THE FOLLOWING PRECAUTIONS: "DO NOT CONTINUE TO PULL HANDLE SPOOL BEYOND TACTILE RESISTANCE AS THIS MAY PREMATURELY DEPLOY CLIP. FAILURE TO KEEP ENDOSCOPE AS STRAIGHT AS POSSIBLE WHEN INSERTING DEVICE CAN RESULT IN DIFFICULT PASSAGE.¿ THE INSTRUCTIONS FOR USE ALSO STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE, DUODENOSCOPE, OR COLONOSCOPE.¿ FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOT NUMBERS CONFIRMED THAT THE LOTS 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 POST POLYPECTOMY CLIPPING IN THE CECUM, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE ASSISTANT REMOVED THE DEVICE FROM THE PACKAGE, UNCOILED AND TESTED IT. IT OPENED AND CLOSED SMOOTHLY WITHOUT ISSUE. THE CLIP WAS ADVANCED THROUGH THE COLONOSCOPE AND WHEN THE TIP OF THE CLIP EXITED THE SCOPE, THE CLIP HAD FALLEN OFF ALREADY [DEPLOYED IN THE ENDOSCOPE]. AN UNINTENDED 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 |
|---|---|---|---|---|---|---|---|
| 1583933 | INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE | PKL, LIGATOR, HEMORRHOIDAL | PKL | WILSON-COOK MEDICAL INC | W4773418 | 00827002580107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | OLYMPUS, EGD 2.8MM CHANNEL. |