BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNIVERSAL ELECTROSURGICAL PAD

    MDR report key: 3853362 · Received May 28, 2014

    Report

    Report Number
    2110898-2014-00034
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 28, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    PMA / PMN Number
    K971446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS OBTAINED ON (B)(4) 2014 THAT DOCUMENTED THE INJURY TO BE A THIRD DEGREE BURN. BASE ON PROFESSIONAL EXPERT OPINION THIS WOULD BE A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 15 MINUTES FROM THE TIME THE SURGERY BEGUN, THERE WAS A SMELL SIMILAR TO A "BURNT WIRE". MORE ENERGY WAS REQUIRED FROM THE ELECTROSURGERY UNIT DURING SURGERY (10 TO 20 WATTS MORE). THE ALARM ON THE ELECTROSURGERY UNIT DID NOT ACTIVATE DURING THE SURGERY. DURING THE SURGERY, AS A PRECAUTION, THE ADHESION OF THE PLATE TO THE PT SKIN WAS NOT CONFIRMED. THE INJURY WAS 8CM X 2 CM ON THE LEFT FLANK. BASED ON THE PHOTOS, A HEALTH PROFESSIONAL WITHIN THE COMPANY PROVIDED AN OPINION THAT THE INJURY APPEARED TO BE A THIRD DEGREE BURN. THE LESION HAD A BLACK COLOR TO IT. PT WAS UNDERGOING A TOTAL PROSTHESIS OF THE LEFT KNEE. THE LENGTH OF SURGERY WAS 4 HOURS AND PT WAS IN A SUPINE POSITION. THE MEDICAL INTERVENTION AS REPORTED WAS NOT CLEAR AND STATED; THE MEDICAL INTERVENTION REQUIRED SURGICAL CLEANING IN THE SITE OF THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314654 3M UNIVERSAL ELECTROSURGICAL PAD ELECTROSURGICAL PATIENT RETURN ELECTRODE GEI 3M HEALTH CARE NA 2016-07 JX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other