BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15X12MM DSP TNG LLETZ LOOP

    MDR report key: 6072763 · Received November 2, 2016

    Report

    Report Number
    1717344-2016-01007
    Event Type
    Injury
    Date Received
    November 2, 2016
    Report Date
    October 6, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    HGI
    PMA / PMN Number
    K931338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE INCIDENT DEVICE CONFIRMED THE REPORTED EVENT. VISUAL INSPECTION FOUND A SECTION OF THE TUNGSTEN LOOP OF THE ELECTRODE TO BE MISSING. BOTH ENDS OF THE LOOP WERE STILL ATTACHED TO THE BODY OF THE ELECTRODE. ONE OF THE ATTACHED SECTIONS WAS BENT. THE ELECTRODE SHOWED SIGNS OF CHARRING WHERE THE TUNGSTEN LOOP ATTACHES TO THE BODY OF THE ELECTRODE. THE CUSTOMER REPORTED THAT THE GENERATOR WAS SET 120W IN THE CUT MODE AND 60W IN COAG MODE. THESE SETTING EXCEED THE MAXIMUM RECOMMENDED POWER SETTINGS. THIS DEVICE SHOULD NOT BE USED IN COAG MODE. THE INSTRUCTIONS FOR USE STATE THAT THE MAXIMUM POWER SETTING FOR A LOOP ELECTRODE IN THE PURE CUT OR BLEND MODE SHOULD 55W. THE IFU ALSO STATES LOOP ELECTRODES ARE NOT DESIGNED FOR USE IN THE COAGULATION MODE. DO NOT ACTIVATE THE GENERATOR IN COAG WHILE USING A LOOP ELECTRODE. LOOP BREAKAGE MAY RESULT.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: 11/2/2016. THE INCIDENT DEVICE 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 FEMALE PATIENT WHO WAS HAVING COLPOSCOPY + REMOVAL OF MIRENA IUD, LLETZ PROCEDURE AND RE-INSERTION OF MIRENA. DURING THE FIRST PASS OF THE PRODUCT FOR THE LOOP BIOPSY THE THEATRE MANAGER DESCRIBED THE LOOP AS SHORTING OUT AND REPORTED THAT A SPARK AND A NOISE EMITTED FROM THE DISTAL END OF THE TUNGSTEN LOOP. UPON THE SURGEON'S EXAMINATION OF THE PRODUCT, THE LOOP HAD APPROXIMATELY 6-8MM OF WIRE MISSING. THE SURGEON SPENT APPROXIMATELY 5 MINS LOOKING FOR THE MISSING SECTION OF WIRE BOTH VISUALLY AND VIA TACTILE TOUCH BUT COULD NOT FIND THE WIRE. THE LOOP WAS REPLACED AND THE CASE CONTINUED WITH A SECOND CERVICAL PASS WITHOUT FURTHER COMPLICATION. THERE WAS NO ADDITIONAL BLEEDING OR PAIN REPORTED AFTER THE INCIDENT. THE GENERATOR SETTINGS WERE CUT: 120W, COAG: 60W. THE PATIENT WAS X-RAYED AND THE RESULT WAS NEGATIVE. NO FOREIGN BODIES/METAL FRAGMENTS WERE PRESENT. THE PATIENT IS DOING WELL AND HAS NOT REQUIRED ANY ADDITIONAL FOLLOW-UP AS A CONSEQUENCE OF THIS INCIDENT. ISPLAYED A STICKER STATED THE LAST SERVICE WAS 2011. THE UNIT HAD AN ELECTROSURGERY CHECK BY THE HOSPITAL BIOMEDS WITHIN THE LAST 12 MTHS, FOR AN ELECTRICAL SAFETY CHECK ONLY. IT APPEARS THAT THIS UNIT HAS NOT HAD A CALIBRATION AND SERVICE FOR SOME TIME,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724738 15X12MM DSP TNG LLETZ LOOP ES ACCESSORY HGI COVIDIEN LP E1560 0115DX

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other COVIDIEN FORCETRIAD SN (B)(4)