BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    MDR report key: 39624 · Received September 4, 1996

    Report

    Report Number
    1527736-1996-00052
    Event Type
    Malfunction
    Date Received
    September 4, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 30, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE: D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE STONE RETRIEVAL SHAFT DETACHED FROM THE INSTRUMENT AND FELL INTO THE PT'S ABDOMEN. IT WAS RETRIEVED WITHOUT DIFFICULTY, BUT DID REQUIRE SOME TIME TO REMOVE. PHOTOGRAPH OF THE BROKEN INSTRUMENT INSIDE THE PT WAS RETURNED TO CO. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other