BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RH ROTATING HEAD SKIN STAPLER

    MDR report key: 2013316 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00970
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT (A) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH 10 STAPLES IN THE TRACK. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY; THE INSTRUMENT FIRED AND FORMED ALL THE STAPLES AS INTENDED. INSTRUMENT (B) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH 16 STAPLES IN THE TRACK. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY; THE INSTRUMENT FIRED AND FORMED ALL THE STAPLES AS INTENDED. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BOTH DEVICES FIRED STAPLES THAT WERE MALFORMED AND WERE FALLING OUT OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RH ROTATING HEAD SKIN STAPLER SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1