BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACLIP DISPOSABLE CARTRIDGE, 10MM CLIPS

    MDR report key: 1084813 · Received July 30, 2008

    Report

    Report Number
    1320894-2008-00112
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED TO CONMED CORPORATION. THE COMPLAINT INFO INCLUDING PRODUCT NUMBER AND LOT CODE WILL BE GIVEN TO THE MANUFACTURING SITE FOR THE ENGINEER TO DO A REVIEW OF THE DEVICE HISTORY RECORD, AND PRODUCTION RECORDS. WHEN CLOSING OF THE INVESTIGATION IS COMPLETED, I WILL SEND YOU A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER APPLICATION OF THE FIRST CLIP, THE DEVICE JAWS REMAINED IN THE CLOSED POSITION ON THE CYSTIC ARTERY. THE SURGEON TRIED UNSUCCESSFULLY TO OPEN THE JAWS. A HEMORRHAGE TOOK PLACE, THEN HE CONVERTED THE PROCEDURE INTO A LAPAROTOMY AND CONSEQUENT ANASTOMOSIS, AND SUTURE VASCULAR INJURY. THIS PROLONGED THE HOSPITALIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACLIP DISPOSABLE CARTRIDGE, 10MM CLIPS LAPAROSCOPIC CLIPS FZP DESIGN STANDARDS CORP NA 0705231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other