BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 4110274 · Received September 12, 2014

    Report

    Report Number
    1037905-2014-00354
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 15, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FHN
    PMA / PMN Number
    K132809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. 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 CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. INSTRUCTIONS FOR USE STATE TO PERMANENTLY DEPLOY CLIP, PULL HANDLE SPOOL TOWARD HANDLE THUMB RING UNTIL CLIP DETACHES. NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP. INSTRUCTIONS FOR USE STATE IF CLIP DEPLOYMENT DEVICE IS USED WITH ENDOSCOPE IN A TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR. PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS 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 MFG 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 · 1

    DURING A COLONOSCOPY PROCEDURE, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. A LOT OF DIFFICULTY WAS EXPERIENCED DEPLOYING THE CLIP. THE CLIP WAS EVENTUALLY ABLE TO BE DEPLOYED INSIDE THE PT. ANOTHER CLIP WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. OTHER THAN THE DEPLOYED CLIP, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566658 INSTINCT ENDOSCOPIC HEMOCLIP FHN, LIGATOR, HEMORRHOIDAL FHN WILSON-COOK MEDICAL INC. W3420073

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR OLYMPUS COLONOSCOPE (UNK MODEL NUMBER)