BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX, INC

    MDR report key: 4605192 · Received March 13, 2015

    Report

    Report Number
    3007593903-2015-00004
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 10, 2015
    Report Date
    March 12, 2015
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K022856
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED TO THE MFR, IT IS NOT POSSIBLE TO DETERMINE IF THE INJURY WAS THE RESULT OF A PRIMARY MEDICAL DEVICE MALFUNCTION, A CONCOMITANT MEDICAL DEVICE MALFUNCTION, IMPROPER SURGICAL TECHNIQUES, OR SOME OTHER UNK ENVIRONMENTAL FACTOR. A FOLLOW-UP REPORT WILL BE PROVIDED IF AND WHEN FURTHER INFO IS RECEIVED. MFR'S INTERNAL REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    AFTER SUCCESSFULLY FINISHED BTB ACL REPAIR, A BURNING OF 3RD DEGREE WAS RECOGNIZED AT PT'S (FEMALE, (B)(6)) UPPER LEG AREA WHERE THE RETURN ELECTRODE WAS PLACED. PT RECEIVED FURTHER TREATMENT TO TAKE CARE OF THE BURNING. OPES CONSOLE SETTINGS: BLEND, CUT 150, COAG 50, PINTPOINT, PRESSET 9, NO CANNULA WAS USED, NACL 9G/1000ML, PROBE WAS USED FOR 3 MINUTES AT END OF SURGERY IN ORDER TO CLEAN FOSSA INTERCONDYLARIS. PROBE WAS NOT IN CONTACT TO OTHER DEVICES. PT POSITION WAS ACL POSITION, LEG DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172804 ARTHREX, INC ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL CORPORATION AR-9600

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention RETURN ELECTRODE WITH CABLE.| ARTHREX, INC, (B)(4) DISPOSABLE SPLIT ADULT,