BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 1943707 · Received January 3, 2011

    Report

    Report Number
    3005075853-2011-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED FOR CONTINUITY AND WAS FOUND TO BE CONFORMING. IT WAS TESTED ON A TEST MEDIA AND PERFORMED AS EXPECTED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE

    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 LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS USED CONNECTED WITH THE VIO (ERBE). THE DEVICE COULD NOT PERFORM DRY CUTTING. BOTH DEVICES WERE REPLACED WITH OTHER DEVICES AT THE SAME TIME AND CONNECTED WITH THE VIO. THE NEW DEVICES FUNCTIONED WITHOUT ANY PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ERBE GENERATOR