BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLASTIC ELECTROSURGICAL DISSECTOR

    MDR report key: 6776713 · Received August 9, 2017

    Report

    Report Number
    1038548-2017-00137
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 31, 2017
    Report Date
    October 6, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    PMA / PMN Number
    K930666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) 88-5227 DEVICES WERE RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL EVALUATION BY THE QUALITY ENGINEER AND LEAD QUALITY TECHNICIAN CONFIRMED THE REPORTED FAILURE. UPON EXAMINATION OF THE ELECTROSURGICAL INSTRUMENT, THERE WAS BLACK CHARRING ON THE METAL TIP NEAR THE INSULATION AND THE OUTER LAYER OF THE INSULATION HAD BURNED AWAY ¿ INCH FROM THE TIP. OBSERVATIONS OF CHARRING AND PEELING WERE ALSO PRESENT IN THAT AREA THAT HAD BURNED AWAY. THE RIGHT CURVED DISSECTOR INSULATION HAS A JAGGED EDGE AT THE END OF THE SHAFT FACING THE INSIDE OF THE TIP. THE INSTRUCTIONS FOR USE IFU 26-2905 STATES, ACTIVATING THE ELECTROSURGICAL UNIT WHILE SIMULTANEOUSLY SUCTION/IRRIGATION MAY ALTER THE PATH OF THE ENERGY. IF THIS SITUATION OCCURRED IT CAN RESULT IN BURNING THE INSULATION. OTHER POSSIBLE REASONS THIS PRODUCT COULD HAVE FAILED: INSTRUMENT HAD A DEFECT IN THE TUBING NOT SEEN WITH THE NAKED EYE AND THEREFORE WAS MISSED DURING INSPECTION. INSULATION HAD A CRACK IN IT PRIOR TO SURGERY AND ATTENDS DID NOT CHECK INSTRUMENTS. DEVICE WAS DROPPED COULD HAVE CAUSE CRACK. HARSH DETERGENT FOR CLEANING INSTRUMENT COULD HAVE DAMAGE DEVICE INSULATION. ACCORDING TO BD RECORDS EIGHT (8) DEVICES (4 SETS) WERE MANUFACTURED FROM THIS SAME PRODUCT LOT AND THIS IS THE ONLY ONE REPORTED AS FAILING DURING USE. BD RECORDS FOR THIS LOT INDICATES THE DEVICE WAS MANUFACTURED AND PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE WHICH INCLUDES VISUAL AND FUNCTIONAL TESTING VIA HYPOT TESTING TO CHECK THE INTEGRITY OF THE INSULATION PRIOR TO LEAVING THE FACILITY. AS THE EXACT REASON FOR FAILURE IS UNKNOWN WE ARE UNABLE TO EXACTLY DETERMINE THE ROOT CAUSE OF THIS REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. THE ROOT CAUSE COULD NOT BE DETERMINED THROUGH THE INVESTIGATION. IT HAS BEEN RECOMMENDED TO REVIEW PRODUCT INFORMATION, IFU IFU 26-2905 IN PARTICULARLY THE CAUTION, HANDLING AND CARE SECTIONS. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PRODUCT IS BRAND NEW AND THE SHIELDING IS COMING OFF/BURNING AWAY BEFORE THE CASE IS COMPLETE. NO PATIENT HARM OCCURRED. ON 01AUG2017 ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTED, THERE WAS NO PATIENT INJURY OR INTERVENTION, THERE WAS NO CONTACT WITH OTHER INSTRUMENTS, THE OTHER INSTRUMENTS IN THE FIELD WHILE DEVICE WAS IN USE WERE ENDO BREAST RETRACT PN#88-5217, ENDO CAUTERY HANDLE PN# 88-5300, 10MM 30 DEG RIGID SCOPE PN# 502-457-030, THE ENDOSCOPIC BREAST AUGMENTATION, TRANS-AXILLARY WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563099 ENDOPLASTIC ELECTROSURGICAL DISSECTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC 88-5227 887590

    Patients

    Seq Age Sex Outcome Treatment
    1