BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* STABILITY SLEEVE

    MDR report key: 2932718 · Received January 29, 2013

    Report

    Report Number
    3005075853-2013-00355
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DOES THIS TROCAR HAVE THE OPTIVIEW TECHNOLOGY? ASKU. WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? ASKU. IF SO, DID THE "NOISE" PREVENT INSUFFLATION? ASKU. WAS THERE A DROP IN PRESSURE? ASKU. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ASKU. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ASKU. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? ASKU. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ASKU.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. THE DEVICE DOES NOT HAVE AN OBTURATOR. THE OBTURATOR IS THE PIECE OF THE TROCAR THAT HAS THE BATCH STAMPED. NO BATCH NUMBER WAS AVAILABLE; THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TROCAR WAS LEAKING. IT IS UNKNOWN IF THERE WAS A DEVICE INSERTED WHEN THE LEAKING OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39581 ENDOPATH** XCEL* STABILITY SLEEVE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1