BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC METZENBAUM SCISS CVD S/S 178MM

    MDR report key: 2386256 · Received November 18, 2011

    Report

    Report Number
    2916714-2011-00018
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Report Date
    November 11, 2011
    Manufacturer
    AUGUST REUCHLEN GMBH
    Product Code
    LRW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING EVALUATED AT THE MFG SITE. AESCULAP INC HAS REQUESTED, BUT NOT YET RECEIVED ADD'L INFO REGARDING THE SURGICAL PROCEDURE INCLUDING DATE OF AND TYPE OF SURGERY.

    Description of Event or Problem · 1

    BROKE AT THE DISTAL TIP DURING USE. NO PT INJURY OR PROLONGING OF SURGERY WAS REPORTED. SURGEON NOTICED THE TIP WAS BROKEN, BUT WAS NOT SURE IF IT WAS BROKEN PRIOR TO SURGERY OR DURING SURGERY SO THEY CALLED FOR AN X-RAY. PT HAD AN X-RAY WHICH WAS NEGATIVE FOR RETAINED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC METZENBAUM SCISS CVD S/S 178MM LRW LRW AUGUST REUCHLEN GMBH MD496

    Patients

    Seq Age Sex Outcome Treatment
    1