BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM

    MDR report key: 5722487 · Received September 13, 2004

    Report

    Report Number
    1527736-2004-03041
    Event Type
    Malfunction
    Date Received
    September 13, 2004
    Report Date
    August 22, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SENT: 09/13/2004. MODEL AND LOT #, IS THIS A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PT?; DEVICE MANUFACTURE DATE, EVALUATION CODES: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    EVENT WAS REPORTED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLERS - ENDOSCOPIC GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK