BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSUTURE SYSTEM RELOAD UNIT FOR SUTURE ASSISTANT

    MDR report key: 6069465 · Received November 1, 2016

    Report

    Report Number
    3005075853-2016-06218
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K972679
    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). BATCH # M93H0L. THE ANALYSIS RESULTS FOUND THAT THE SW110 CARTRIDGE (B) WAS RECEIVED WITH THE CARTRIDGE PLATE DISLODGED. DUE TO THE CONDITION OF THE CARTRIDGE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCRUB AND THE SURGEON WAS UNABLE TO LOAD ONTO SUTURE ASSIST TWO FAILED RELOADS. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719652 ENDOSUTURE SYSTEM RELOAD UNIT FOR SUTURE ASSISTANT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA N4L431

    Patients

    Seq Age Sex Outcome Treatment
    1