BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 19380592 · Received May 23, 2024

    Report

    Report Number
    1037905-2024-00280
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 17, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K212323. INVESTIGATION EVALUATION: ONE OF THE PRODUCTS SAID TO BE INVOLVED WAS RETURNED IN A BIOHAZARD BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE 2ND REPORTED DEVICE WAS NOT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE DEVICE IN A COILED POSITION AND BOTH CLIP JAWS WERE MISSING. THE MISSING CLIP JAWS WERE NOT INCLUDED IN THE RETURN. UPON FURTHER INSPECTION UNDER VISUAL MAGNIFICATION, IT COULD BE SEEN THAT BOTH CLIP JAWS WERE MISSING, HOWEVER THE NITINOL STRIPS WERE STILL PRESENT. WHEN THE HANDLE WAS ACTUATED, INITIALLY NOTHING WOULD OCCUR AND THERE WAS A LARGE AMOUNT OF RESISTANCE PRESENT, HOWEVER, EVENTUALLY THE DRIVE WIRE EXTENDED FORWARD WITH THE NITINOL STRIPS AND THE HOUSING STAYED ATTACHED TO THE CATH ATTACH. A FUNCTION TEST WAS NOT POSSIBLE, DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE DEVICE SHOWS THAT THE DEVICE DOES NOT HAVE ANY KINKS ON THE SHEATH. THE HOUSING, COIL CATH, AND HOUSING TABS SHOW NO SIGNS OF STRESS, MISHANDLING, OR SCRATCHES. VISUAL EVALUATION OF THE DEVICE CAN CONFIRM THAT THE JAWS AND STYLET WIRES ARE NO LONGER PRESENT ON THE DEVICE. THE DRIVER, NITINOL STRIP, AND DRIVE WIRE ARE STILL COMPLETE. THE DRIVER WINDOWS ARE IN CONTACT AND SHOW NO SIGNS OF WEAR OR MISSING RIBS. FUNCTIONAL TESTING FOR THE MISSING JAWS CANNOT BE FULLY CONFIRMED AS THERE ARE NO STYLET WIRES PRESENT TO MONITOR MOVEMENT OF THE DRIVER. ADDITIONALLY IT CAN BE CONFIRMED THAT THE DRIVER IS CRIMPED TO THE DRIVE WIRE BASED ON THE CURRENT STATE OF THE DEVICE. HOWEVER, THE DRIVER COULD NOT RETURN INTO THE HOUSING WITH ACTUATION OF THE DRIVE WIRE. THE REPORTED COMPLAINT OF MISSING JAWS CAN BE CONFIRMED AFTER VISUAL AND FUNCTIONAL EVALUATION. THE JAWS WERE PLACED INSIDE THE RIBS OF THE DRIVER AND WITH THE MOVEMENT OF THE DRIVE WIRE GET PULLED DOWN INTO THE HOUSING. THE COIN DEPTHS OF THE JAWS COULD NOT BE EVALUATED AS THEY WERE NOT PRESENT IN THE DEVICE. THE WIDTH OF THE FORMED DRIVER COULD NOT BE ACCURATELY MEASURED, AS THE WIDTH IS ALTERED COMPARED TO PRE-DEPLOYMENT STATUS OF THE CLIP. ALL CLIP DEVICES ARE 100% VERIFIED FOR FUNCTIONALITY PER WSI-138, THIS INCLUDES THE PRESENCE OF BOTH JAWS AND STYLET WIRES TO ALLOW FOR SMOOTH OPEN AND CLOSE OPERATION. ROOT CAUSE CAN NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR (PT) W4791836 (800) WAS REVIEWED. (PT) W4791836 (800) WAS MANUFACTURED DECEMBER 2023. THERE WERE RELEVANT DEFECTS NOTED IN THE FQC/MANUFACTURING CHECKLISTS FOR STYLET WIRES SHORT = 4 AND JAW DEFECTS = 50. THE DEVICE HISTORY RECORD FOR THE LOT # SAID TO BE INVOLVED WAS REVIEWED. NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO THE COMPLAINT WERE CONTAINED IN THE ASSOCIATED DHR. THE NONCONFORMANCE DOCUMENTATION SUPPORTS THE AFFECTED DEVICE(S) WERE DISPOSITIONED APPROPRIATELY PRIOR TO RELEASE OF THIS LOT. THERE IS NO EVIDENCE NONCONFORMING PRODUCT WAS RELEASED FOR DISTRIBUTION. IN AN EFFORT TO HEIGHTEN AWARENESS OF THE POTENTIAL CONNECTION OF THE CUSTOMERS REPORT TO THE CURRENT MANUFACTURING PROCESSES PRODUCTION PERSONNEL WERE NOTIFIED. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED AND ANY RELEVANT DEFECTS HAVE BEEN NOTED. VISUAL EVALUATION OF THE DEVICE CAN CONFIRM THAT THE JAWS AND STYLET WIRES ARE NO LONGER PRESENT ON THE DEVICE. THE ROOT CAUSE OF THE JAWS COMING OFF IS UNKNOWN. ALL DEVICES ARE INSPECTED PRIOR TO BEING PACKAGED AND SHIPPED." 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 CONFIRMED THE DEVICES RELEASED AND DISTRIBUTED 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.

    Additional Manufacturer Narrative · 0

    510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW UP EMDR WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    DURING A COLONOSCOPY, THE PHYSICIAN USED TWO COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS INITIALLY REPORTED THAT THERE WAS AN UNSPECIFIED FAULT FOUND. ON 28 APR 2024 WE RECEIVED REPORTABLE INFORMATION THAT THE CLIP ENTERED THE SCOPE AND THE CLIP WAS OPENED. WHEN THE CLIP WAS CLOSED, BOTH CLIP ARMS FELL OFF, LEAVING THE TWO NITINOL STRIPS LEFT, HAPPENED WITH A SECOND CLIP (SAME MALFUNCTION) BUT WORKS FINE WITH THIRD CLIP. THE CLIP ARMS WERE LEFT IN THE PATIENT TO PASS NATURALLY. 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
    1452331 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC W4789736 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SCOPE, UNKNOWN MAKE AND MODEL