BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2142264 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02615
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RECEIVED WITH CAP SEPARATED FROM THE SLEEVE. THE ORIFICES OF THE CAP AND THE POSTS OF THE SLEEVE WERE NOTED TO BE CRACKED. THE STOPCOCK VALVE BROKEN INSIDE A SAMPLE BAG WAS RECEIVED. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RECEIVED WITH CAP SEPARATED FROM THE SLEEVE. THE ORIFICES OF THE CAP AND THE POSTS OF THE SLEEVE WERE NOTED TO BE BROKEN. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # H9032H EXPIRATION DATE: 12/2015 MANUFACTURING DATE: 01/2011 (B)(4) SLEEVE (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (C) WAS RECEIVED WITH CAP SEPARATED FROM THE SLEEVE. THE ORIFICES OF THE CAP AND THE POSTS OF THE SLEEVE WERE NOTED TO BE CRACKED. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE C ADDITIONAL INFORMATION: BATCH # UNK EXPIRATION DATE: UNK MANUFACTURING DATE: UNK (B)(4) SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPARATOMY PROCEDURE, A BOO SOUND WAS HEARD WHEN A FORCEPS WAS REMOVED FROM THE DEVICE. THE PNEUMOPERITONEUM APPARATUS HAD ABDOMINAL AIR PRESSURE AT 10 MMHG/MIN AND HIGH FLOW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H4375C

    Patients

    Seq Age Sex Outcome Treatment
    1 FORCEPS