INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
Report
- Report Number
- 1037905-2022-00078
- Event Type
- Malfunction
- Date Received
- February 21, 2022
- Date of Event
- January 25, 2022
- Report Date
- March 18, 2022
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- PKL
- UDI-DI
- 00827002580107
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
510(K): K212323. THE INVESTIGATION IS ONGOING. A FOLLOW UP EMDR REPORT WILL BE SENT WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT FOR THE DEVICE EVALUATION AND COMPLETED INVESTIGATION.
510(K): K212323. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. HOWEVER, 9 SEALED DEVICES FROM THE LOT NUMBER SAID TO BE INVOLVED WERE RETURNED AND EVALUATED. SEALED DEVICES FROM LOT NUMBER SAID TO BE INVOLVED: OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICES, FROM THE SAME LOT NUMBER AS THE USED DEVICE, COULD NOT CONFIRM THE REPORT FOR DIFFICULTY WITH DEPLOYMENT. THE SAMPLES WERE FUNCTION TESTED PER PROTOCOL STUDY FOR FUNCTIONAL TESTING FOR OPEN/CLOSE AND FULL DEPLOYMENT NOT ON SIMULATED TISSUE, TO REPLICATE A WORST CASE SCENARIO. THE CLIPS OPENED AND CLOSED, AND DEPLOYED AS INTENDED, NO ENDOSCOPIC MANEUVERS WERE REQUIRED TO AID IN DEPLOYMENT. 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: USED DEVICES, NOT RETURNED: 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. SEALED DEVICES, RETURNED: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCTS FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE STATES, "NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP." PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES 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 W/ EMR (SIGMOID COLON), A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE WAS USED. WHEN THE CLIP WAS ADVANCED THROUGH THE ENDOSCOPE, THE USER CLOSED THE CLIP AND THE CLIP WOULD NOT RELEASE OR SEPARATE FROM THE HOUSING. THE PHYSICIAN HAD TO SHAKE THE DEVICES UNTIL THE RELEASED [DIFFICULT TO DEPLOY]. 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 |
|---|---|---|---|---|---|---|---|
| 2444167 | INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE | PKL, LIGATOR, HEMORRHOIDAL | PKL | COOK ENDOSCOPY | G58010 | W4520083 | 00827002580107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | OLYMPUS CF-190 SCOPE |