BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 58500 · Received December 18, 1996

    Report

    Report Number
    9680598-1996-00212
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    May 9, 1996
    Report Date
    December 17, 1996
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    RECEIVED VOLUNTARY MEDWATCH #1010191 STATING "ON 6/6, I WAS NOTIFIED THAT THE WHITE PLASTIC CEILING (SIC) RING FROM A CANNULA SLIPPED OFF INTO THE ABDOMEN DURING A LAPAROSCOPIC SPLENECTOMY. THE SURGEON IMMEDIATELY NOTICED IT, RETRIEVED IT AND CHANGED THE DEVICE. THE PT SUFFERED NO ADVERSE EFFECTS." THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ EES-JUAREZ NA J42D91

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other