BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 1884148 · Received October 14, 2010

    Report

    Report Number
    3007069406-2010-00010
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT RETAIN THE DEVICE. HOWEVER, THE LOT NUMBER WAS PROVIDED. AN INSPECTION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ISSUES DURING THE MANUFACTURING OF THIS LOT. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A PHONE INTERVIEW WAS CONDUCTED WITH THE PHYSICIAN, DURING WHICH HE STATED THE FOLLOWING: HE WAS NOT FILING A COMPLAINT CONCERNING THE PERFORMANCE OF THE DEVICE OR EVENT IN QUESTION. THE SKIN BURN OCCURRED FOLLOWING THE PROCEDURE AS THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT'S MOUTH AFTER THE ADENOID TIP FELL OFF. WITH THE DEVICE STILL ACTIVATED AND SUCTION ENGAGED, THE PHYSICIAN ACCIDENTALLY TOUCHED THE SKIN OF THE PATIENT'S CHEEK. THE SUCTION HELD THE DEVICE TO THE PATIENT'S SKIN UNTIL THE PHYSICIAN PULLED IT FREE. THE PHYSICIAN CONSULTED WITH A PLASTIC SURGEON IMMEDIATELY FOLLOWING THE INJURY WHO STATED THAT THE BURN WAS 1ST TO 2ND DEGREE AND WOULD MOST LIKELY HEAL SPONTANEOUSLY WITHOUT ADDITIONAL INTERVENTION. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FOLLOWING A TONSILLECTOMY AND ADENOIDECTOMY, THE ADENOID TIP FELL OFF THE DEVICE. PT SUSTAINED SKIN BURN AND TAKEN TO RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TNA TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. NA 30408

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other NOT AVAILABLE