BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 215529 · Received March 9, 1999

    Report

    Report Number
    1527736-1999-01380
    Event Type
    Malfunction
    Date Received
    March 9, 1999
    Report Date
    February 11, 1999
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT HTE TSB35 INSTRUMENT DOES NOT STAPLE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other