BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE

    MDR report key: 1172467 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01850
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 9/22/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE GDT ETHICON ENDO-SURGERY, LLC NA E4K078

    Patients

    Seq Age Sex Outcome Treatment
    1