BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 42784 · Received October 2, 1996

    Report

    Report Number
    1527736-1996-00202
    Event Type
    Malfunction
    Date Received
    October 2, 1996
    Report Date
    September 26, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. 8/30/96 CONTACTED AFFILIATE "DID CLIPS FALL INTO THE PATIENT.?" RETRIEVED?-DSH 9/6/96 INFO REC'D-DSH. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP THE CLIPS FELL OUT. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other