BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 14491280 · Received May 24, 2022

    Report

    Report Number
    1037905-2022-00249
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 24, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K212323. INVESTIGATION EVALUATION: THE PRODUCTS SAID TO BE INVOLVED WERE RETURNED IN OPEN POUCHES FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABELS MATCH THE PRODUCTS RETURNED. DEVICE 1: THE DEVICE WAS RETURNED WITH THE CLIP HOUSING ATTACHED TO THE DISTAL END OF THE DEVICE, ALL OTHER CLIP COMPONENTS WERE MISSING (DRIVER, BOTH JAWS, NITINOL STRIP, AND PINS). WITH HANDLE MANIPULATION THE DRIVE WIRE MOVED FREELY THROUGH THE CLIP HOUSING. THE DEVICE WAS NOT FUNCTION TESTED IN THE SCOPE DUE TO THE CONDITION OF THE RETURNED DEVICE. A VISUAL EXAMINATION OF THE DISTAL END UNDER MAGNIFICATION DID NOT IDENTIFY A ROOT CAUSE. THE CLIP JAWS, DRIVER, NITINOL STRIP, AND PINS HOLDING IT IN PLACE WERE NOT PRESENT OR RETURNED WITH THE DEVICE. DEVICE 2: THE DEVICE WAS RETURNED IN THE CLOSED POSITION. ONE OF THE CLIP JAWS WAS MISSING, THE NITINOL STRIP IS STILL PRESENT. THE CLIP OPENS AND CLOSES DURING HANDLE MANIPULATION. THE DEVICE WAS NOT FUNCTION TESTED IN THE SCOPE DUE TO THE CONDITION OF THE RETURNED DEVICE. A VISUAL EXAMINATION OF THE DISTAL END UNDER MAGNIFICATION DID NOT IDENTIFY A ROOT CAUSE. THE CLIP JAW AND PINS HOLDING IT IN PLACE WERE NOT PRESENT OR RETURNED WITH THE DEVICE. THE REST OF THE DISTAL END COMPONENTS HAD NO ANOMALIES OR DAMAGE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION. THE FOLLOWING INFORMATION WAS PROVIDED: "DEVICE 1: THE DEVICE WAS RETURNED WITH THE MOLDED HOUSING ATTACHED TO THE DISTAL END OF THE DEVICE. THE JAWS, NITINOL STRIP, DRIVER, AND PINS ARE MISSING. THE MISSING COMPONENTS WERE NOT RETURNED WITH THE DEVICE. DEVICE 2: THE DEVICE WAS RETURNED IN THE CLOSED POSITION. ONE OF THE CLIP JAWS IS MISSING. THE MISSING JAW WAS NOT RETURNED WITH THE DEVICE. IT HAS BEEN CONFIRMED THAT THE TIP COMPONENTS ARE MISSING ON BOTH DEVICES. NEITHER OF THE DEVICES WERE FUNCTIONALLY TESTED IN THE SCOPE DUE TO THE CONDITION OF THE RETURNED DEVICES. WITHOUT THE MISSING COMPONENTS, ROOT CAUSE COULD NOT BE DETERMINED." 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: DEVICE 1: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED, THE CLIP DRIVER, BOTH JAWS, NITINOL STRIPS, AND PINS WAS DETACHED AND NOT RETURNED WITH THE DEVICE. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. DEVICE 2: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED, ONE OF THE CLIP JAWS WAS DETACHED AND NOT RETURNED WITH THE DEVICE. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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.

    Description of Event or Problem · 0

    DURING A COLONOSCOPY, TWO INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES WERE USED. IT WAS REPORTED THAT TWO CLIPS POPPED OFF DURING THE PROCEDURE AND WERE RETRIEVED FROM THE PATIENT. THE PHOTOS PROVIDED SHOW THE CLIPS WITH THE ARMS DETACHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; THE DETACHED CLIP PORTIONS WERE RETRIEVED. 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
    1697503 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC G58010 W4555558 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PENTAX ENDOSCOPE - MODEL UNKNOWN.