BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO NON-STICK BIPOLAR FORCEPS, 22 CM (8.7") BAYONET, W/IRRIGATION, 1.0 MM TIP

    MDR report key: 10452772 · Received August 26, 2020

    Report

    Report Number
    3003923584-2020-00013
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 30, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    GEI
    PMA / PMN Number
    K070997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ONGOING. WE WILL PERFORM A FOLLOW-UP REPORT AS SOON AS IT IS FINISHED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED FROM CUSTOMER ON (B)(6) 2020. CUSTOMER STATED THAT THE TIP OF BIPOLAR FORCEPS BROKE OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922284 DORO NON-STICK BIPOLAR FORCEPS, 22 CM (8.7") BAYONET, W/IRRIGATION, 1.0 MM TIP DORO NON-STICK BIPOLAR FORCEPS GEI PRO MED INSTRUMENTS GMBH 5006-08 910310

    Patients

    Seq Age Sex Outcome Treatment
    1