BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 158333 · Received March 18, 1998

    Report

    Report Number
    1527736-1998-00774
    Event Type
    Malfunction
    Date Received
    March 18, 1998
    Date of Event
    February 18, 1998
    Report Date
    February 18, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING 3.49723. EES #.981203/C. D5,6; G4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    TRACKING #.49723. EES #. 981203/C. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ALALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THE DEVICE WOULD NOT FIRE COMPLETELY. AN ENDOGIA WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other