BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PROXIMATE PLUS MD SKIN STAPLER

    MDR report key: 301701 · Received October 18, 2000

    Report

    Report Number
    1527736-2000-05108
    Event Type
    Malfunction
    Date Received
    October 18, 2000
    Report Date
    September 22, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (2) PMW35 WERE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE STAPLES DID NOT FORM PROPERLY. A THIRD PMW WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PROXIMATE PLUS MD SKIN STAPLER SKIN STAPLERS GDT ETHICON ENDO-SURGERY, INC. NA N4J47K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other