BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PLUS MD

    MDR report key: 3113395 · Received April 30, 2013

    Report

    Report Number
    3113395
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 13, 2012
    Report Date
    April 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE SKIN STAPLER THE HANDPIECE BROKE. THE PATIENT WAS HAVING A BILATERAL BREAST REDUCTION. THERE WAS NO HARM TO THE PATIENT. THE STAFF JUST RETRIEVED ANOTHER STAPLER. THE SECOND STAPLER ALSO FAILED. I WILL BE ENTERING ANOTHER REPORT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SEE ABOVE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186156 PROXIMATE PLUS MD STAPLER, SKIN GDT ETHICON ENDO-SURGERY, LLC *+H20PMW351R* J4AV3X

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR UNKNOWN. THIS OCCURRED IN 9/12. THIS EVENT DID| OCCUR IN THE OR.