BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 2851548 · Received November 29, 2012

    Report

    Report Number
    3005075853-2012-05395
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    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). DID ANY PIECE FALL INTO THE PATIENT? IF SO WAS IT RETRIEVED AND HOW. THE DOCTOR COMMENTED NO PIECE FELL INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED WITH THE ELECTRODE TIP BROKEN OFF FROM THE SHAFT AND RETURNED WITH THE DEVICE. NO FURTHER FUNCTIONAL ANALYSIS COULD BE PERFORMED DUE TO DEVICE'S RECEIVING CONDITION. NO CONCLUSION COULD BE DRAWN AS TO WHAT CAUSED THE TIP TO BREAK OFF

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, THE ELECTRODE WAS DETACHED OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO 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. NA J91930

    Patients

    Seq Age Sex Outcome Treatment
    1