BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER

    MDR report key: 1792190 · Received August 10, 2010

    Report

    Report Number
    3005075853-2010-04560
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 14, 2010
    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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE IS BEING RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGICAL TEAM STATED THAT THE STAPLER SEEMS TO WORK FINE, BUT THE STAPLES DO NOT SECURE THE WOUND (THEY ARE LOOSE) SO THEY HAVE TO PUT STERI-STRIPS OVER THE SITE TO KEEP THEM IN PLACE. NO ADDITIONAL INFORMATION PROVIDED. DEVICE IS RETURNING.

    Description of Event or Problem · 1

    THERE IS NO DEVICE TO RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1