BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON MAXI-FORCEPS

    MDR report key: 3124708 · Received May 14, 2013

    Report

    Report Number
    2183680-2013-00024
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED IN A CLEAN STATE, NO COAG BUILD UP ON THE JAWS, JAWS OPEN/CLOSE, ROTATE AS DESIGNED, KYNAR INSULATION IS IN PLACE, USING THE CORD THAT WAS RETURNED BY THE CUSTOMER, THE DEVICE WAS CONNECTED TO THE GENERATOR SET AT 24 WATTS COAG, DEVICE ACTIVATED AND COAGULATED AS DESIGNED. NO LOSS OF COAGULATION FUNCTION OR SPARKING WAS SEEN DURING FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS (B)(4) THAT DURING A LAPAROSCOPIC MYOMECTOMY, THERE WAS A LARGER SPARK BETWEEN JAWS THAN USUAL. THE JAWS GOT BURNED. THE DEVICE HAD DIFFICULTY IN SEALING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PT. THERE ARE THREE OTHER DEVICES ASSOCIATED WITH THIS INCIDENT. PLEASE SEE THE FOLLOWING MFR. REPORT NUMBERS: 2183680-2013-00024, 2183680-2013-00025, 2183680-2013-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213745 ETHICON MAXI-FORCEPS MAXI-FORCEPS HIN GYRUS MEDICAL, INC. 6602-105 JF500328

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK