BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSEAL

    MDR report key: 2053000 · Received April 13, 2011

    Report

    Report Number
    3005075853-2011-01475
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL SALPINGO-JEJUNOSTOMY AND OOPHORECTOMY THE BLADE WAS STUCK IN THE CLOSED POSITION. THE SURGEON HAD BEEN UNABLE TO RELEASE THE BLADE ABOUT 5 MINUTES. THE SURGEON WHILE THE RN WAS ON THE PHONE WAS ABLE TO FORCE THE INSTRUMENT OPEN. THE RN REPORTED NO PATIENT CONSEQUENCE. THE LIGHT WAS ON TO REPLACE INSTRUMENT. THEY WERE GOING TO REPLACE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR