BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR PULSAR REFURBISHED

    MDR report key: 2867780 · Received December 11, 2012

    Report

    Report Number
    1226420-2012-00088
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 5, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K073057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4). THE PULSAR GENERATOR IS A SURGICAL RF GENERATOR AND, AS SUCH, DELIVERS HIGH POWER RF ENERGY TO THE TIP OF THE PLASMABLADE HANDPIECE TO CUT OR COAGULATE PATIENT TISSUE. IF THE SURGEON'S GLOVE HAND IS IN THE PATH OF THE BLADE IT IS EXPECTED THAT IT WOULD BE CUT BY THE ENERGY. THE LOW (BUT WITHIN LIMIT) VDD POWER TO THE U18 DSP IC WAS THE CAUSE FOR THE F8 ERROR BUT WAS UNRELATED TO THE REPORTED INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD, RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (B)(6).

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE PLASMABLADE TO CUT THRU TISSUE, WHEN HE SLICED THROUGH HIS GLOVE AND CUT HIS FINGER.

    Description of Event or Problem · 1

    SURGEON WAS UTILIZING PLASMABLADE AND SLICED THROUGH GLOVE AND CUT HIS FINGER. CUT WAS ADDRESSED WITH OTC MEDICAL INTERVENTION AND CASE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR PULSAR REFURBISHED GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1