BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 82048 · Received February 20, 1997

    Report

    Report Number
    9680598-1997-00026
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTRECTOMY, THE WHITE SEAL/SEAT AT THE 45 DEGREE FLAPPER VALVE FELL INTO THE PT'S PELVIS. THE SEAL WAS REMOVED. THERE WAS NO CONSEQUENCE TO THE PT. 1/2/97 THE VALVE SEAT WAS FOUND IN THE VAGINAL CANAL. NO ADD'L INSTRUMENTS WERE NEEDED TO COMPLETE THE CASE. CLINICAL FOLLOW UP: 1/27/97 1615 MESSAGE AND 800 NUMBER LEFT FOR THE SURGEON TO CALL BACK. 1/28/97 1350 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ EES-JUAREZ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2