BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* SLEEVE

    MDR report key: 2142268 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02616
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WAS THERE A DROP IN PRESSURE? YES. IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? NO WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? WENT FROM 17 TO 7 IN A FEW SECONDS. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? SLEEVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? 5MM SCISSOR AND A FLEX 45. IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. 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-CONFORMANCES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE WAS LEAKING AT THE SEAL OF THE TROCAR SLEEVE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1