BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 3212753 · Received July 2, 2013

    Report

    Report Number
    1037905-2013-00496
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. 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 EVAL. 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 AN ENDOSCOPY PROCEDURE FOR TREATMENT OF A BLEEDING SITE IN THE DUODENUM, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. ONCE THE ENDOSCOPE AND CLIP WERE IN POSITION, THE PHYSICIAN NOTED THAT THE SITE IN THE DUODENUM WAS NO LONGER BLEEDING. THE CLIP WAS ATTACHED TO THE SITE BUT THE DEPLOYMENT DEVICE WOULD NOT RELEASE THE CLOSED CLIP. THE CLIP COULD NOT BE REOPENED. THEY PULLED ON THE DEPLOYMENT DEVICE, PULLING THE CLIP OFF THE SITE. THE REMOVAL OF THE CLOSED CLIP CAUSED BLEEDING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. DUE TO THE PERFORMANCE OF THE CLIP, THE PT WAS SENT TO INTERVENTIONAL RADIOLOGY (IR) FOR EMBOLIZATION. THE PT PRESENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300514 INSTINCT ENDOSCOPIC HEMOCLIP MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)