BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC NEEDLE HOLDER

    MDR report key: 45355 · Received October 28, 1996

    Report

    Report Number
    MW1010173
    Event Type
    Injury
    Date Received
    October 28, 1996
    Date of Event
    October 21, 1996
    Report Date
    October 22, 1996
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES
    Product Code
    FHQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING INSTRUMENT DURING LAPAROSCOPIC BURCH PROCEDURE JAWS OF INSTRUMENT SEPARATED FROM INSTRUMENT AND FELL INTO PT. BOTH JAWS WERE TRACED AND REMOVED FROM PT. NO APPARENT INJURY TO PT, BUT INCIDENT PROLONGED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC NEEDLE HOLDER LAPAROSCOPIC NEEDLE HOLDER FHQ MARLOW SURGICAL TECHNOLOGIES M4100S *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention