BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2111811 · Received May 26, 2011

    Report

    Report Number
    1717344-2011-00431
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S INITIAL REPORT STATED THAT THE DISPOSABLE PENCIL SPARKED DURING USE. THE SURGEON COMPLAINED THAT THE (B)(4) FOOT PEDAL (A NON-COVIDIEN PRODUCT) WAS NOT WORKING PROPERLY WITH THE COVIDIEN GENERATOR. THE SURGEON USED COAG ON 30W THEN PUSHED IT TO 35W THEN TO 40W AND THE DISPOSABLE PENCIL SPARKED. THE DISPOSABLE PENCIL AND PAD WERE DISPOSED OFF. FOLLOW-UP WITH THE SITE FOUND THAT (B)(6) POST OPERATIVELY FROM THE COLONOSCOPY, THE PATIENT RETURNED AND WAS FOUND TO HAVE A PERFORATION AT THE PLACE OF THE POLYP REMOVAL IN THE BOWEL. THE PATIENT WAS TRANSPORTED TO A HOSPITAL AND THE PERFORATION REPAIRED. PATIENT IS NOW HOME AN IS DOING OK. THE DOCTOR ASKED THAT THE GENERATOR BE CHECKED AS A PRECAUTION AND MENTIONED HE HAD SEEN SPARKS WHEN THE DEVICE WAS TURNED UP HIGHER. THE HAND PIECE WAS MANUFACTURED BY (B)(4) AND THE PAD WAS MANUFACTURED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R ES PENCIL: (B)(4) MANUFACTURER - LOT # UNK| PATIENT RETURN ELECTRODE: (B)(4) - LOT # UNK