BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1882079 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06064
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH® XCEL, WITH OPTIVIEW, TECHNOLOGY. ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? YESIF SO, DID THE "NOISE' PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. YES, WHISTLING AND HISSING.WAS THERE A DROP IN PRESSURE? YES IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YESWHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? 2 CANISTERSWERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? GASKETWAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? YES IF SO, WHAT DEVICE? 5MM REUSEABLE BABCOCKS, GRASPERS AND ENSEALWAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? YESADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED:WHAT TYPE OF INSUFFLATOR WAS BEING USED? STRYKER SYSTEM, NOT SURE OF THE MODEL # BUT A RELATIVELY NEW HD TOWER.WAS THERE A SPECIFIC TROCAR THAT CAUSED THE CONVERSION? NOT SURE WHICH ONE¿ IT SEEMED THAT ALL OF THE 12MM PORTS WERE LEAKING. IF AN INSTRUMENT WAS PLACED IN A PORT THAN THE ABDOMEN WOULD COMPLETELY DEFLATE.DID THE 5MM TROCAR CONTRIBUTE TO THE CONVERSION? I DO NOT BELIEVE SO. HE WANTED THEM SENT BACK FOR ANALYSIS JUST IN CASE.WERE THERE ANY OTHER FACTORS THAT LED TO THE CONVERSION? NO. HE STATED THAT HE WOULD HAVE BEEN ABLE TO PERFORM THE ROUTINE LAP CHOLE IF HE COULD HAVE ACHIEVED PNEUMO.CAN YOU PLEASE PROVIDE THE DETAILS OF THE CHANGE IN THE PATIENT'S POST OPERATIVE CARE? UNKNOWN. (B)(6). DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? ONLY MORBID OBESITY. PATIENT'S CURRENT STATUS? UNKNOWN. WERE THE TROCARS REPROCESSED? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE USED DURING A ROUX EN Y, GASTRIC BYPASS AND A LAPAROSCOPIC CHOLECYSTECTOMY ON THE PATIENT. THE TROCARS WERE LEAKING THROUGHOUT THE PROCEDURE. AT THE END, THEY CONVERTED TO OPEN PROCEDURE IN ORDER TO PERFORM THE LAPAROSCOPIC CHOLECYSTECTOMY, BECAUSE ANY TIME THE DEVICES WERE INSERTED THE AIR WOULD LEAK OUT.

    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 Required Intervention