BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 254618 · Received December 13, 1999

    Report

    Report Number
    1527736-1999-06371
    Event Type
    Malfunction
    Date Received
    December 13, 1999
    Date of Event
    November 16, 1999
    Report Date
    November 16, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE (1) ER 320 WAS USED DURING A GALL BLADDER PROCEDURE. IT WAS REPORTED THAT THE CLIPS WOULD NOT CLOSE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA M4F70M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other