BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 38135 · Received August 30, 1996

    Report

    Report Number
    9680598-1996-00007
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 23, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,3,4;B6,7;D10: INFOR UNAVAILABLE. 8/20/96 1540 COURTESY CALL TO RISK MGMT. 8/20/96 1520 WAS TOLD TO CALL SHARYN PRIOR TOMORROW. 8/21/96 AFTER 9AM. TKB 8/21/96 1440 SHARYN SAID SHE HAD NO PT INFO. TKB 8/21/96 1450 NNCL SENT. TKB G4: INFO UNAVAILABLE F1: USER FACILITY SHOULD NOT HAVE BEEN SELECTED. NO MEDWATCH WAS RECEIVED FROM USER FACILITY. G3: HEALTH PROFESSIONAL WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLELCYSTECTOMY. THE 355L WOULD NOT STAY ARMED. ALSO, IT DID NOT APPEAR THE SAFETY SHIELD WAS RETRACTING BACK FAR ENOUGH. THERE WAS NO CONSEQUENCE TO THE PT. ON 8/13/96 REP REPORTS ANOTHER 355L WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other