BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 296127 · Received September 12, 2000

    Report

    Report Number
    1527736-2000-04279
    Event Type
    Malfunction
    Date Received
    September 12, 2000
    Date of Event
    August 17, 2000
    Report Date
    August 18, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. IT WAS REPORTED THAT THE DEVICE LOCKED OUT ON THE FIRST FIRE. A NEW BOX WAS OPENED. THE CUSTOMER DID NOT KNOW TO TRY A RELOAD. THERE WAS NO PT CONSEQUENCE. 8/23/2000: ADDITIONAL INFO RECEIVED: THE PRODUCT CODE WAS A TLC55.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTERS - CONVENTIONAL GAG ETHICON ENDO-SURGERY, INC. NA N4HY34

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other