BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 14515753 · Received May 26, 2022

    Report

    Report Number
    1037905-2022-00257
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 20, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K212323. THE PRODUCT WAS RETURNED TO THE APPROVED SUPPLIER FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED A FOLLOW-UP EMDR REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K212323. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN 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. A VISUAL EXAMINATION CONFIRMED THE CLIP HOUSING HAS SEPARATED FROM THE COIL CATHETER BUT REMAINS ATTACHED TO THE END OF THE DRIVE WIRE, IN A CLOSED POSITION. THE CLIP COULD NOT BE REOPENED. UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COILED CATH APPEARED TO BE FLATTENED/MISSHAPEN AT THE DISTAL END PREVENTING THE CATH ATTACH FROM MOVING PROPERLY. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION. THE FOLLOWING INFORMATION WAS PROVIDED: UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COIL CATH APPEARS TO BE SLIGHTLY FLATTENED/MISSHAPEN AT THE DISTAL END. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION CONFIRMED THE CLIP HOUSING HAS SEPARATED FROM THE COIL CATHETER BUT REMAINS ATTACHED TO THE END OF THE DRIVE WIRE, IN A CLOSED POSITION. THE CLIP COULD NOT BE REOPENED. UNDER VISUAL MAGNIFICATION, THE DISTAL END COMPONENTS WERE VIEWED AND THE COILED CATH APPEARED TO BE MISSHAPEN AT THE DISTAL END. THE DEFORMATION OF THE COIL CATH AT THE DISTAL END OF DEVICE TIP INDICATES THAT THE TIP WAS NOT NESTED PROPERLY PRIOR TO CRIMPING THE TABS. THE OPEN AND CLOSE FUNCTION OF THE INSTINCT PLUS DEVICE IS FULLY VERIFIED IN THE MFG INSTRUCTIONS AND DOCUMENTED ON THE PROCESS TRAVELER. ROOT CAUSE - HUMAN ERROR. 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 INVESTIGATION EVALUATION OF THE RETURNED DEVICE CONFIRMED THE COMPLAINT. THE SUPPLIER PROVIDED THE FOLLOWING INFORMATION: "THE ASSIGNABLE CAUSE IS HUMAN ERROR. THE OPERATORS WILL BE ADVISED OF THE COMPLAINT AND RETRAINED ON PROCEDURES." 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 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.

    Description of Event or Problem · 0

    DURING REMOVAL OF A DUODENAL MASS, THE PHYSICIAN USED AN INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. AS REPORTED, "WHEN THEY WENT TO OPEN THE CLIP, THE INTERNAL WIRE EXTENDED OUT BUT THE CLIP DID NOT OPEN. THREE ADDITIONAL COOK CLIPS AND 4 CLIPS FROM ANOTHER MANUFACTURER WERE USED TO COMPLETE THE INTENDED PROCEDURE." [TROMBONING]. 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
    889506 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4566561 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Male OLYMPUS ERCP SCOPE - UNKNOWN MODEL