BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 1884173 · Received October 14, 2010

    Report

    Report Number
    3007069406-2010-00011
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT RETAIN THE DEVICE. HOWEVER, THE LOT NUMBER WAS PROVIDED. A REVIEW 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. SUBJECT HAD TONSILLECTOMY ON (B)(6) 2010, RETURNED WITH TONSILLAR FOSSA RE-BLEED ON (B)(6) 2010 AND WAS ADMITTED TO THE HOSPITAL FOR CAUTERIZATION. SUBJECT MONITORED OVERNIGHT AFTER BLEEDING CONTROL ESTABLISHED WITH A TRADITIONAL ELECTROSURGICAL DEVICE AND RELEASED THE FOLLOWING DAY. SUBJECT FOLLOW-UP CONDUCTED ON (B)(6) 2010 AND IS REPORTED TO BE NEAR FULL RECOVERY. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PT PARTICIPATING IN TONSILLECTOMY STUDY HAD A RE-BLEED FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TNA TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. NA 27305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NOT AVAILBLE