BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3180078 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00391
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOW PRECAUTION - "IF CLIP DEPLOYMENT DEVICE IS USED WITH ENDOSCOPE IN TORQUED OR RETROFLEXED POSITION, CLIP DEPLOYMENT DIFFICULTIES CAN OCCUR." THE INSTRUCTIONS FOR USE ALSO STATES "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 ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED ON A 6MM POST-POLYPECTOMY SITE NEAR THE CECUM. THE CLIP WAS ATTACHED TO THE TISSUE SITE BUT WOULD NOT RELEASE FROM THE DEPLOYMENT DEVICE. THE CLIP WOULD NOT REOPEN. THEY JIGGLED IT AROUND AND EVENTUALLY THE CLIP REOPENED. THEY REMOVED THE CLIP AND DEPLOYMENT DEVICE FROM THE PT. ANOTHER CLIP OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE. 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
    269737 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNKNOWN TYPE)