BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE *ENDO CLIP* II ML

    MDR report key: 45860 · Received September 17, 1996

    Report

    Report Number
    1219930-1996-00120
    Event Type
    Malfunction
    Date Received
    September 17, 1996
    Date of Event
    August 20, 1996
    Report Date
    August 20, 1996
    Manufacturer
    UNITED STATED SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY AND THE JAWS SCISSORED. THE SURGEON COMPLETED WITH ANOTHER INSTRUMENT. THE HOSPITAL HAS REPORTED THAT NOO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE *ENDO CLIP* II ML DISPOSABLE APPLIER GCJ UNITED STATED SURGICAL CORPORATION NA N6E272J

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR