BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONICS / COVIDIEN

    MDR report key: 6951330 · Received October 16, 2017

    Report

    Report Number
    MW5072766
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO PT HARM BUT FOUR EVENTS WHERE BOVIE TIPS SPARKED OR IGNITED WITHIN THE LAST WEEK. THESE ARE PRODUCTS WE HAVE USED FOR YEARS. NO NEW PRODUCT, NO NEW SUPPLIER, SETTINGS ON CAUTERY MACHINE ALL APPROPRIATE. DOS: (B)(6) 2017; PROSTATE PACK - SLC69PRCIS, LOT #773098. TIP REF # E1455 - LOT 62520076X (ALL STOCK HAS BEEN SEQUESTERED. I DO NOT SEE ON THE REPORT THAT YOU PROVIDED ME WITH LAST WEEK THAT THIS PACK COMES WITH TIPS). THIS LOT WAS BROUGHT INTO THE ROOM AND "IGNITED". TIP REF # E1455-6, LOT #71460008X (ALL STOCK HAS BEEN SEQUESTERED. THIS LOT WAS BROUGHT INTO THE ROOM AND "SPARKED AND ATTEMPTED TO IGNITE." PENCIL REF # E2515H, LOT #71840019X, ONE PENCIL WAS SALVAGED. DOS: (B)(6) 2017, LAPAROTOMY PACK - SBA73LPCID, LOT # 759357. TIP REF # E1455, LOT # 63020092X (ALL STOCK HAS BEEN SEQUESTERED AND PACKS ARE BEING TAGGED WITH "STOP" NOTES WITH BAGS FOR THE FREE FLOATING TIPS WITHIN THE PACKS TO BE DISCARDED AND REPLACEMENTS ARE..."IS THE PRODUCT COMPOUNDED: NO, IS THE PRODUCT OVER-THE-COUNTER: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732156 MEDTRONICS / COVIDIEN BOVIE PENCIL AND TIPS - ELECTROSURGICAL GEI MEDTRONIC / COVIDIEN E1455 62520076X (TIP)
    732157 MEDTRONIC / COVIDIEN BOVIE PENCIL AND TIPS - ELECTROSURGICAL GEI MEDTRONIC / COVIDIEN E1455-6 71460008X (TIP)
    732158 MEDTRONIC / COVIDIEN BOVIE PENCIL AND TIPS - ELECTROSURGICAL GEI MEDTRONIC / COVIDIEN E2515H 71840019X (PENCIL)
    732159 MEDTRONIC / COVIDIEN BOVIE PENCIL AND TIPS - ELECTROSURGICAL GEI MEDTRONIC / COVIDIEN E1455 63020092X (TIP)

    Patients

    Seq Age Sex Outcome Treatment
    1