BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO TYPE CIRCUMCISION CLAMP DISP CHROME PLATED NEWBORN

    MDR report key: 7138657 · Received December 20, 2017

    Report

    Report Number
    MW5074163
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 14, 2017
    Manufacturer
    FINE SURGICAL INSTRUMENT INC.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CIRCUMCISION PROC PERFORMED BY PHYSICIAN USING A 1.1 GOMCO CIRCUMCISION CLAMP. THE CLAMP WAS APPLIED; THE SCREW THREADED WITHOUT DIFFICULTY. GENERALLY THE GOMCO NEEDS TO BE UNSCREWED TO RELEASE THE CLAMP, BUT THIS TIME THE GOMCO AND CLAMP CAME OFF WITHOUT BEING UNSCREWED. SILVER NITRATE STICK WAS USED TO CONTROL BLEEDING. AFTER THE EVENT AND UPON INSPECTION, THERE WAS A SMALL DEFECT NOTED ON THE THREAD OF THE POST ON THE GOMCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916155 GOMCO TYPE CIRCUMCISION CLAMP DISP CHROME PLATED NEWBORN GOMCO SIZE 1.1 HXD FINE SURGICAL INSTRUMENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA