BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1812593 · Received August 24, 2010

    Report

    Report Number
    3005075853-2010-04817
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 3, 2010
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE (B)(4) DEVICE (A) FOUND EVIDENCE THAT THE DEVICE HAD BEEN REPROCESSED BY ASCENT HEALTH CARE SOLUTIONS. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE RETURNED. THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION; THE DEVICE WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VIEWSONIC DISPLAY FOR THE ACUITY CENTRAL STATION HAD FAILED. THIS RESULTED IN A TEMPORARY INABILITY TO MONITOR PATIENTS CENTRALLY UNTIL THE CUSTOMER REPLACED THE MONITOR. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENTS. NOTE 1 FOR BLOCK A: THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICES WERE LEAKING THROUGHOUT THE CASE. THE SEAL APPEARS TO SEPARATE AWAY FROM SHAFT AND CAUSING SIGNIFICANT PNEUMO LEAKAGE. INSUFFLATION WAS 900L/2.5 HRS RESULTED IN SIGNIFICANT POST OP PAIN FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1