BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE SKIN STAPLER 35 WIDE

    MDR report key: 1810029 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07541
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 21, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFO, THE MFG RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MFG OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLES WERE MALFORMED. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE SKIN STAPLER 35 WIDE GDT ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GU0P

    Patients

    Seq Age Sex Outcome Treatment
    1