BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 4810474 · Received June 1, 2015

    Report

    Report Number
    8020045-2015-00043
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. AS THE INJURY WAS ON THE BUTTOCK CHEEKS AND NOT UNDERNEATH THE DISPERSIVE ELECTRODE, WE ASSUME THAT THE BURN WAS CAUSED BY A DIRECT ELECTRICAL CONTACT BETWEEN THE PT AND THE OPERATING ROOM TABLE DUE TO THE PRESENCE OF MOISTURE THERE (RESIDUAL DAMPNESS AFTER URINATING EVENT) AND NOT BY THE DISPERSIVE ELECTRODE. AFTER SEVERAL REQUESTS TO OBTAIN ADDITIONAL INFO, WE GOT INFORMED BY OUR CUSTOMER "THAT THE PERCEIVED SKIN ISSUES HAD COMPLETELY RESOLVED WITHIN 24 HOURS". THEY HAVE CLOSED THE COMPLAINT. NO INFO WAS MADE AVAILABLE TO US ON HOW THE INJURY WAS TREATED. BASED ON THE RECEIVED INFO, WE WILL CLOSE OUT THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) WE HAVE BEEN INFORMED ABOUT "A (B)(6) LB PT WAS GETTING A T AND A PROCEDURE AT (B)(6) MEDICAL CENTER, (B)(6) OUTPATIENT SURGERY DEPT. ON (B)(6) (...) WHICH RESULTED IN TWO PT BURNS. THE PT WAS PLACED ON TOP OF AN OPERATING ROOM TABLE DRAPED WITH LINEN SHEET, BLANKET DRAW SHEET. M2K-01 USED WITH FORCE FX GENERATOR. THE PT URINATED PRIOR TO THE ONSET OF THE PROCEDURE. NURSING DRIED PT AND PLACED FOLDED UP BLANKET, DISPOSABLE DRAPE AND A DISPOSABLE IMPERVIOUS ABSORBENT PAD UNDER PT. PT DID NOT HAVE CATHETER OR DIAPER. UPON INITIATION OF ELECTROSURGERY THERE WAS NOT ENOUGH POWER AT THE PENCIL SO CIRCULATOR DISCONNECTED MS #0845 AND APPLIED 0865C MEGADYNE PAD (WEIGHT LIMIT UP TO 33LBS). SURGERY PROCEEDED. MS WAS UNPLUGGED. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THE PTS BUTTOCKS WAS RED AND ONE SMALL BLISTER WAS PRESENT ON EACH BUTTOCK CHEEK. THE ABSORBENT PAD AND BLANKET UNDER THE PT WERE DAMP. CIRCULATOR NURSE INDICATED THE BLISTERS WERE NOT THERE AT THE SKIN ASSESSMENT PRIOR TO SURGERY." NO FURTHER DETAILS HAVE BEEN SPECIFIED DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353276 MEGADYNE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RSW22A30 40220-0744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other