BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED RETURN ELEC

    MDR report key: 4192273 · Received October 22, 2014

    Report

    Report Number
    1717344-2014-00924
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INCIDENT GROUNDING PAD FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GROUNDING PAD HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT BURN OCCURRED DURING THE PROCEDURE. THE BURN DID NOT OCCUR AT THE GROUNDING PAD SITE. THE GROUNDING PAD WAS PLACED ON THE PATIENT'S BACK. THE VAS DEFERENS AND THE BACK OF PERITONEUM WERE FOUND BURNED WHILE THE PHYSICIAN WAS WORKING ON A TESTIS AS HE WAS PULLING IT BY HAND. THERE WERE NO FORCEPS OR OTHER INSTRUMENTS IN THE SURGICAL FIELD AT THAT TIME. THE SITE DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673437 PED RETURN ELEC PEDIATRIC PATIENT GROUNDING PAD JOS COVIDIEN LP E751025

    Patients

    Seq Age Sex Outcome Treatment
    1 VIO SCALPEL, CONMED PENCIL