BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS, TENACULUM

    MDR report key: 3966741 · Received June 3, 2014

    Report

    Report Number
    1418479-2014-00028
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP
    Product Code
    HCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 WILL BE COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RW (B)(4) FACILITY ON (B)(4) 2014. DEVICE NOW BEING SENT TO ENDOPLUS FOR INVESTIGATION. RICHARD WOLF CONSIDERS THIS MATTER OPEN. WHEN WE RECEIVE INFORMATION, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT DURING A CASE, AFTER FORCEPS WERE INSERTED INTO PATIENT AND OPENED, THE INSTRUMENT WOULD NOT CLOSE. DOCTOR HAD TO USE A BABCOCK IN ANOTHER INCISION IN ORDER TO CLOSE DEVICE IN QUESTION. WHEN DEVICE WAS REMOVED AND TESTED, IT WORKED. DOCTOR BEGAN TO USE DEVICE AND ONCE AGAIN HAD SIMILAR EVENT OCCUR. NO PATIENT INJURY REPORTED. MINIMAL DELAY IN CLOSING DEVICE FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323471 FORCEPS, TENACULUM FORCEPS HCZ RICHARD WOLF MEDICAL INSTRUMENTS CORP 8370.26 51000189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention