BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE SEMI-RIGID ALLIGATOR FORCEPS

    MDR report key: 394580 · Received May 13, 2002

    Report

    Report Number
    1519132-2002-00041
    Event Type
    Malfunction
    Date Received
    May 13, 2002
    Date of Event
    April 18, 2002
    Report Date
    May 10, 2002
    Manufacturer
    ACMI NORWALK
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE JAWS OF THE GYA-5 GRASPER FELL OFF INSIDE A PATIENT'S UTERUS. VARIENCE REPORT SHOWS A TIME OF 13:35. DR WAS ABLE TO FINISH CASE BY USING OTHER INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE SEMI-RIGID ALLIGATOR FORCEPS * HIH ACMI NORWALK GYA-5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other