BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEANEY- BALLENTINE HYSTERECTOMY FORCEP

    MDR report key: 19819942 · Received July 23, 2024

    Report

    Report Number
    MW5157512
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 18, 2024
    Manufacturer
    CODMAN /SYMMETRY SURGICAL GMBH
    Product Code
    HCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ABDOMINAL HYSTERECTOMY. A STRAIGHT HEANEY INSTRUMENT TIP BROKE OFF INSIDE THE PATIENT. TWO PIECES BROKE. BOTH PIECES ACCOUNTED FOR AND VERIFIED BY BOTH SURGEONS PERFORMING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357298 HEANEY- BALLENTINE HYSTERECTOMY FORCEP FORCEPS, SURGICAL, GYNECOLOGICAL HCZ CODMAN /SYMMETRY SURGICAL GMBH 30-5801

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female