BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING

    MDR report key: 15454604 · Received September 20, 2022

    Report

    Report Number
    15454604
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 29, 2022
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    JEK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ANGLED CUP BITER WAS BEING USED BY DR. TO OBTAIN A LYMPH NODE BIOPSY. HANDLE OF BITER CAME APART WHILE IN USE. INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE FIELD. X-RAY WAS OBTAINED PRIOR TO SURGICAL INCISION CLOSURE. ABSENCE OF RETAINED OBJECT WAS VERIFIED BY DR. AND RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644422 PILLING FORCEPS, BIOPSY, BRONCHOSCOPE (RIGID) JEK TELEFLEX INCORPORATED IPN007777

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Female