BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACLIP DISPOSABLE CARTRIDGE 10MM CLIPS

    MDR report key: 1013354 · Received March 13, 2008

    Report

    Report Number
    1320894-2008-00036
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 12, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WILL BE SENT TO THE MFG SITE FOR AN EVAL. AS SOON AS THE MFG ENGINEERS HAVE COMPLETED THEIR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING THE LAPAROSCOPIC CHOLECYSTECTOMY OPERATION MADE IN 2008, TO THE PT UNDER THE DIAGNOSIS OF STONED CHOLESTITIS; DURING THE CLIPPING OF THE CYSTIC ARTERY, THE CLIP WAS LOCKED BY HOLDING THE CYSTIC ARTERY AND DID NOT LET IT GO DESPITE EVERY KIND OF MANEUVERS. THE CLIP COULD BE REMOVED TO THE OUTSIDE OF THE ABDOMEN BY CUTTING THE CYSTIC ARTERY WITH SCISSORS AND IN THE MEANWHILE, HEMORRHAGE DEVELOPED. THE HOSP STAY WAS PROLONGED 2 DAYS. THE CYSTIC ARTERY COULD HARDLY BE CLOSED WITH A CLIP OF ANOTHER BRAND BY BEING HELD BY DISSECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACLIP DISPOSABLE CARTRIDGE 10MM CLIPS LAPAROSCOPIC CLIPS GDO DESIGN STANDARDS CORP 0710191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization