BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISCHLER STANDARD STRAIGHT BIOPSY PUNCH

    MDR report key: 12778068 · Received November 9, 2021

    Report

    Report Number
    12778068
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 5, 2021
    Manufacturer
    GYNEX CORPORATION
    Product Code
    HFB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A CERVICAL BIOPSY PROCEDURE, THE CERVICAL KEY PUNCH BIOPSY INSTRUMENT WOULD NOT RELEASE THE SPECIMEN BY CUTTING THE TISSUE, NOR WOULD THE INSTRUMENT HANDLE UNLOCK SO THAT THE INSTRUMENT COULD BE REMOVED. MULTIPLE ATTEMPTS MADE BY PHYSICIAN TO UNLOCK THE INSTRUMENT OR COMPLETE THE BIOPSY WERE UNSUCCESSFUL. A SECOND PHYSICIAN WAS ALSO UNABLE TO UNLOCK THE INSTRUMENT. THE PHYSICIAN CUT AROUND THE TIP OF THE INSTRUMENT TO DETACH IT FROM THE CERVIX. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM AND UNDERWENT REPAIR OF THE CERVICAL LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675729 TISCHLER STANDARD STRAIGHT BIOPSY PUNCH FORCEPS, BIOPSY, GYNECOLOGICAL HFB GYNEX CORPORATION 1035

    Patients

    Seq Age Sex Outcome Treatment
    1 11315 DA Female Other