BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 7388871 · Received April 2, 2018

    Report

    Report Number
    1218950-2018-03074
    Event Type
    Injury
    Date Received
    April 2, 2018
    Date of Event
    March 3, 2018
    Report Date
    March 5, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAN NOT CONFIRM SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DURING A MICROSCOPIC INSPECTION OF THE PART, IT WAS OBSERVED THE SPIRAL TIP WAS MISSING FROM THE ELECTRODE. THE INDICATION IS THAT THE FETAL SPIRAL ELECTRODE HAD BEEN OVER ROTATED. THERE ARE NO VISIBLE TOOL MARKS THAT WOULD INDICATE A MANUFACTURING DEFECT (LATENT FAILURE MECHANISM). THIS ISSUE IS MOST CONSISTENT WITH STRESS APPLIED AGAINST THE SPIRAL DURING REMOVAL. THE FAILURE APPEARS CONSISTENT WITH A SINGLE STRESS EVENT, RATHER THAN A FATIGUE FAILURE RESULTING FROM MULTIPLE BEND CYCLES. ADDITIONAL EXAMINATION OF THE PART UNDER MAGNIFICATION SHOWED THAT THE GRAIN STRUCTURE OF THE STEEL (AT THE BROKEN END) EXHIBITED SIGNS OF BEING TWISTED. THE ATTENDING PHYSICIAN REMOVED THE BROKEN SPIRAL TIP FROM THE BABY'S SCALP AND THE FETAL SPIRAL ELECTRODE WAS DISCARDED. NO KNOWN PARTS WERE REPLACED. THERE WAS NO PRODUCT MALFUNCTION. THE FAILURE OF THE SPIRAL IS MOST CONSISTENT WITH INCORRECT USE OF THE PRODUCT (EITHER DURING PLACEMENT OR REMOVAL).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FETAL SCALP ELECTRODE (B)(4) TIP BROKE OFF IN A CHILD¿S SCALP ON (B)(6) 2018, LOT #171743. PER THE PHYSICIAN, THEY ATTEMPTED TO PLACE FETAL SPIRAL ELECTRODE BUT WHEN CORD CAME OUT THE SMALL METAL COIL WAS NO LONGER ATTACHED TO WHITE PLASTIC PIECE. THE PHYSICIAN WAS NOT ABLE TO REMOVE IT MANUALLY AND THEREFORE THE ELECTRODE WAS RETAINED IN THE SCALP. THE ELECTRODE HAS SINCE BEEN REMOVED THROUGH EXCISION WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233426 FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE HGP PHILIPS MEDICAL SYSTEMS 989803137631 171743

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other