BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/OUT CABLE

    MDR report key: 10859811 · Received November 18, 2020

    Report

    Report Number
    2182269-2020-00099
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 21, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10 G4, G7, H2, H3, H6. ONE RF DISPOSABLE GROUNDING PAD WAS RECEIVED FOR EVALUATION. TWO IMAGES WERE SUBMITTED TO PRODUCT PERFORMANCE ENGINEERING. THE IMAGES APPEAR TO SHOW A BURN. FUNCTIONAL TESTING WAS NOT POSSIBLE DUE TO THE CABLE NOT BEING RETURNED. THE PRESENCE OF A HAIR-LIKE FOREIGN MATERIAL ON THE GROUNDING PAD, IN ADDITION TO THE EVENT DESCRIPTION, IS CONSISTENT WITH PLACEMENT OF THE GROUNDING PAD OVER HAIR. THE RF DISPOSABLE GROUNDING PAD INSTRUCTIONS FOR USE (IFU) WARNS ¿AVOID PLACEMENT OVER SCARS, BONY PROMINENCES, PROSTHESIS, HAIR, OR ECG ELECTRODES. FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE SURFACE OF THE GROUNDING PAD MAY RESULT IN SIGNIFICANT ELECTROSURGICAL BURNS AT THE PAD LOCATION¿. A REVIEW OF RECEIVING INSPECTION RESULTS FOR THIS LOT NUMBER CONFIRMED THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2184149-2020-00189. DURING A CERVICAL RF PROCEDURE, THE PATIENT EXPERIENCED A BURN AT THE GROUNDING PAD SITE. PRIOR TO THE PLACEMENT OF THE GROUNDING PAD ON THE RIGHT LOWER BACK, THE SKIN WAS NOT PREPPED. WHEN THE GROUNDING PAD WAS REMOVED, A BLISTERY BURN WAS NOTED. THE PATIENT WILL BE SEEING A PLASTIC SURGEON NEXT WEEK. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324668 DISPOSABLE GROUNDING PAD W/OUT CABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ST. JUDE MEDICAL RF-DGP-L 810320012

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other NT GENERATOR| NT GENERATOR