BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT SLEEVE 5X100MM STABILITY

    MDR report key: 3052456 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01727
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED 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. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. 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. ADDITIONAL INFORMATION: WAS THERE MORE THAN ONE CASE/PATIENT INVOLVED? NO. IF YES, WE NEED TO REPORT EACH ONE SEPARATELY. WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? HISSING. IF SO, DID THE NOISE PREVENT INSUFFLATION? PARTIAL. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? DON'T KNOW. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? SEAL. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? NO. IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE?NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE SEAL HOUSING WAS LEAKING AT THE BEGINNING OF THE CASE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156745 OPT SLEEVE 5X100MM STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1