BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM - LARGE TITANIUM LI

    MDR report key: 1241095 · Received November 21, 2008

    Report

    Report Number
    3005075853-2008-03277
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/21/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ADRENALECTOMY, THE DEVICE HAD BEEN USED WITHOUT INCIDENT. DURING THE FINAL STAGES OF THE PROCEDURE, WHILE CLIPPING THE ADRENAL VEIN, THE JAWS OF THE INSTRUMENT JAMMED CLOSED AND COMPLETELY LOCKED THEREFORE BECOMING COMPLETELY STUCK ON THE ADRENAL VEIN. THE PROCEDURE HAD TO BE CONVERTED TO OPEN. A MEMBER OF THE SURGICAL TEAM SUPPORTED THE INSTRUMENT WHILE THE CONSULTANT PROCEEDED TO OPEN TO AVOID FURTHER INJURY TO THE ADRENAL VEIN. THE VESSEL WAS CLAMPED AND SUTURED TO MAKE IT SAFE AND THE DEVICE WAS FORCIBLY REMOVED. AT THE END OF THE PROCEDURE FURTHER INVESTIGATION OF THE RESULTED IN DR. FIRING A CLIP WHICH WAS MALFORMED AND SCISSORED. SUBSEQUENT FIRING RESULTED IN CLIPS APPEARING NORMAL. THE PATIENT SUFFERED BLOOD LOSS OF 800 ML - NO TRANSFUSION REQUIRED, DELAYED SURGERY TIME, POST-OP RECOVERY AND EXTENDED HOSPITAL STAY. THE PATIENT WAS IN STABLE CONDITION IMMEDIATELY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM - LARGE TITANIUM LI FZP ETHICON ENDO-SURGERY, LLC NA E4M151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention