BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 44283 · Received October 18, 1996

    Report

    Report Number
    1628808-1996-00080
    Event Type
    Malfunction
    Date Received
    October 18, 1996
    Report Date
    October 18, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFORMATION UNAVAILABLE. 10/7/96 MESSAGE AND 800# LEFT ON OFFICE ANSWERING MACHINE FOR MD CALL BACK. KJB. 10/8/96 NNCL SENT. KJB.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE SLIPS WERE NOT LOSING ALL THE WAY. THE DEVICE HAD BEEN USED AT THE SUBXYPHOID SITE WHERE THE 511S WAS INSERTED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC MULTIPLE CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J42K3C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other