INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
Report
- Report Number
- 1037905-2024-00392
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Report Date
- August 12, 2024
- Manufacturer
- WILSON-COOK MEDICAL INC
- Product Code
- PKL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITHIN 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE ADDITIONAL INFORMATION INDICATED THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL. THIS IS THE MOST LIKELY CAUSE OF THIS REPORT. THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. HOWEVER, EVEN IF THE CLIP IS NOT DEPLOYED, DAMAGE CAN OCCUR TO INTERNAL DEVICE COMPONENTS SUCH AS THE DRIVER LEGS. ONCE THIS DAMAGE OCCURS, THE CLIP IS IN A PARTIALLY DEPLOYED STATE AND MAY NOT BE ABLE TO BE OPENED/REOPENED. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. 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. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL, THE COOK AREA REPRESENTATIVE PROVIDED TRAINING IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.
DURING A COLONOSCOPY IN THE COLON AFTER A POLYPECTOMY, THE PHYSICIAN SELECTED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE DOCTOR WANTED TO PUT A CLIP BECAUSE OF BLEEDING. THE NURSE INSERTED THE CLIP AND WHEN IT CAME OUT, IT WAS IMPOSSIBLE TO OPEN IT. IT WAS ALMOST SEPARATED FROM ITS SHEATH [TROMBONING: CLIP HOUSING DETACHED FROM THE CATH ATTACH]. THE NURSE USED A NEW ON TO CLOSE THE BLEEDING. THE NURSE WHO USED THE CLIP WAS VERY STRESSED AND TOLD [THE AREA REP] THAT MAYBE SHE TIGHTENED THE CLIP A LITTLE TOO HARD BEFORE INSERTING INTO THE WORKING CHANNEL OF THE COLONOSCOPE. THE DIFFICULTY IS THAT THEY USE 3 TYPES OF CLIPS DIFFERENT AND SHE IS NEW IN THE SERVICE. A TRAINING OF THE CLIP WAS HELPFUL FOR HER AND NOW, IT MIGHT RUN PERFECTLY. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354480 | INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE | PKL, LIGATOR, HEMORRHOIDAL | PKL | WILSON-COOK MEDICAL INC | G58010 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | COLONOSCOPE FUJI 700 |