BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS, TENACULUM

    MDR report key: 3898958 · Received May 16, 2014

    Report

    Report Number
    1418479-2014-00020
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    January 1, 2012
    Report Date
    January 13, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HCZ
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HANDLE IS MANUFACTURED BY RICHARD WOLF. IT IS THEN SENT TO ENDOPLUS WHERE THEY MANUFACTURE AND ATTACH THE INSULATED SHEATH AND FORCEPS. COMPLETED DEVICE IS THEN RETURNED TO RICHARD WOLF FOR DISTRIBUTION. AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON (B)(4) 2013. DEVICE WAS THEN SENT TO (B)(4) FOR ADDITIONAL INVESTIGATION. INVESTIGATION REVEALED INCORRECT HANDLE HAD BEEN ASSEMBLED ON FORCEPS. MANUFACTURE DATE: NOV 2011. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    DEVICE BROKE, NO INJURY OR DELAY IN PROCEDURE WAS REPORTED. TWO DEVICES INVOLVED, THEY CONSIST OF THE FOLLOWING: 1) TENACULUM (8370.26), REPORT: 1418479-2014-00020; 2) TENACULUM (8370.26), REPORT: 1418479-2014-00021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294607 FORCEPS, TENACULUM FORCEPS HCZ RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8370.26 1N11

    Patients

    Seq Age Sex Outcome Treatment
    1