BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 318162 · Received February 27, 2001

    Report

    Report Number
    1527736-2001-00888
    Event Type
    Malfunction
    Date Received
    February 27, 2001
    Report Date
    January 30, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THAT THE TLC75 WOULD NOT FIRE (NO OTHER DETAILS AVAILABLE). ANOTHER TLC75 DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7972 PROXIMATE LINEAR CUTTER LINEAR CUTTERS - CONVENTIONAL GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other