BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEM-O-LOK ML ENDO 5 APPLIER

    MDR report key: 499369 · Received December 5, 2003

    Report

    Report Number
    1044475-2003-00009
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 7, 2003
    Report Date
    December 5, 2003
    Manufacturer
    WECK CLOSURE SYSTEMS
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON USED HEM-O-LOK ML ENDO5 APPLIER TO LIGATE A CYSTIC ARTERY. AFTER THE CLIP WAS CLOSED ON THE ARTERY, THE APPLIER JAW WOULD NOT REOPEN TO RELEASE THE CLIP. THE SURGEON USED TWO OTHER METAL CLIPS ON EACH SIDE OF HEM-O-LOK CLIP, AND THEN CUT THE CYSTIC ARTERY VESSEL TO REMOVE THE APPLIER AND CLIP FROM THE PT. THERE WAS NO FURTHER COMPLICATION REPORTED AFTER THE SURGERY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK ML ENDO 5 APPLIER LIGATION CLIP APPLIER GDO WECK CLOSURE SYSTEMS NA 890918-013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R