BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACLIP REUSABLE HANDLE W/DISP. CLIP CART

    MDR report key: 1084811 · Received July 30, 2008

    Report

    Report Number
    1320894-2008-00110
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 29, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR THE DEVICE TO BE RETURNED TO CONMED CORP, UTICA, NY. UPON ARRIVAL, WE WILL RETURN THIS DEVICE TO THE MFG SIT FOR HE ENGINEER TO DO AN EVALUATION INVESTIGATION. WHEN THE 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 REUSABLE HANDLE W/DISP. CLIP CART LAPAROSCOPIC CLIP APPLIER GDO DESIGN STANDARDS CORP NA 0705231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other