BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DIPOSABLE SURGICAL TROCAR

    MDR report key: 42877 · Received October 1, 1996

    Report

    Report Number
    9680598-1996-00114
    Event Type
    Malfunction
    Date Received
    October 1, 1996
    Date of Event
    August 26, 1996
    Report Date
    September 27, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    9/11/96 1105 MESSAGE AND 800# LEFT ON SURGEON'S ANSWERING MACHINE. KJB. 9/12/96 NNCL SENT. TSB. 9/12/97 1015 SPOKE WITH SOURCE WHO CONFIRMED THE INFO AS REPORTED BY THE SALES REP. SOURCE STATED SHE DID NOT KNOW ANY ADDITIONAL INFO SUCH AS PATIENT INFO. TSB. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H8-INFO NOT AVAILABLE.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE 512S WOULD ARM BUT WOULD NOT REACTIVATE WHEN REMOVED AND APPLIED AGAIN. A SECOND 512S WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other