BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    MDR report key: 314453 · Received January 29, 2001

    Report

    Report Number
    1527736-2001-00322
    Event Type
    Malfunction
    Date Received
    January 29, 2001
    Date of Event
    June 21, 2000
    Report Date
    January 23, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN EXTERNAL MEDWATCH FORM NUMBER 1020575 THAT THE (1) EPS01 WAS USED DURING A LAP CHOLE PROCEDURE. IT WAS REPORTED BY THE REP THAT THE 5MM HOOK FROM EPS01 5MM HOOK (ENDOSCOPIC) BECAME DETACHED FROM THE ROD DURING THE PROCEDURE TWICE. THE HOOKS REMAIN IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3517 ENDOPATH ELECTROSURGERY PROBE PLUS II ELECTRO-SURGERY - ENDOSCOPIC GEI ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other