BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 57706 · Received October 4, 1996

    Report

    Report Number
    9680598-1996-00117
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    September 2, 1996
    Report Date
    October 4, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    9/11/96 1100 SPOKE TO MARGARET AT THE OFFICE SHE STATED THE SURGEON WILL NOT BE IN UNTIL NEXT WEEK. NNCL SENT. KJB. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INSTRUMENT'S INNER GASKET "FELL OFF" DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH A DETACHED INNER GASKET. NO CONCLUSION COULD BE REACHED AS TO HOW THIS HAD OCCURRED. APPROPRIATE ENGINEERING AND MFG PERSONNEL HAVE BEEN INFORMED OF THIS INCIDENT.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. DEVICE'S WHITE RWING ON THE INNER SEAL FELL OFF. THE RING DID NOT FALL INTO THE PT. A NEW TROCAR WAS INTRODUCED TO COMPLETE THE CASE. 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 ETHICON ENDO-SURGERY, INC. NA J4351C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other