BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOMED EUROPE

    MDR report key: 13041654 · Received December 20, 2021

    Report

    Report Number
    9710376-2021-00004
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    December 20, 2021
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375861530
    PMA / PMN Number
    K990015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO US THAT A PATIENT WAS OPERATED ON IN ABDOMINAL POSITION. DURING INTRAOPERATIVE MRI (IOMR), THE SUBDERMAL NEEDLES WERE LEFT IN THE SCALP. AFTERWARDS, A DEEP BURN OF 3-4 CM IN THE SCALP WAS NOTED PARIETALLY LEFT AT THE SITE OF THE NEEDLES. THE RISK OF BURNS FROM REMAINING NEEDLES DURING MRI EXAMINATION WAS MENTIONED TO BE KNOWN BY THE USER. THEY HAVE ASSESSED THAT THE RISK OF INJURY COULD BE AVOIDED BY USING PT / IR NEEDLES, AS WELL AS THE WAY OF PLACEMENT OF THE NEEDLES. THE USER REPORTED THAT IT WAS KNOWN TO THEM THAT THE NEEDLES ARE USED OUTSIDE THE INTENDED USE. INCIDENT OCCURED ON (B)(6) 2021. MANUFACTURER BECAME AWARE OF THE INCIDENT ON THE 8TH OF DECEMBER 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED TO US THAT A PATIENT WAS OPERATED ON IN ABDOMINAL POSITION. DURING INTRAOPERATIVE MRI (IOMR), THE SUBDERMAL NEEDLES WERE LEFT IN THE SCALP. AFTERWARDS, A DEEP BURN OF 3-4 CM IN THE SCALP WAS NOTED PARIETALLY LEFT AT THE SITE OF THE NEEDLES. THE RISK OF BURNS FROM REMAINING NEEDLES DURING MRI EXAMINATION WAS MENTIONED TO BE KNOWN BY THE USER. THEY HAVE ASSESSED THAT THE RISK OF INJURY COULD BE AVOIDED BY USING PT / IR NEEDLES, AS WELL AS THE WAY OF PLACEMENT OF THE NEEDLES. THE USER REPORTED THAT IT WAS KNOWN TO THEM THAT THE NEEDLES ARE USED OUTSIDE THE INTENDED USE. THE USER INTENDED TO NOTIFY THE MANUFACTURER OF THE INCIDENT TO HIGHLIGHT IN THEIR RISK MANAGEMENT THAT THE NEEDLES HAVE BEEN USED OUTSIDE THE INTENDED USE TO POSSIBLY IMPROVE THE LABELING OF THE DEVICE. THE USER DID NOT REPORT DIRECTLY TO THE MANUFACTURER, INSTEAD REPORTED TO THE (B)(6) AUTHORITY. THE (B)(6) AUTHORITY INFORMED THE MANUFACTURER. THE NEEDLES WERE IN THE PATIENT WHILE BEING IN AN MRI SCANNER. SOME LITERATURE STATES THAT PT/IR NEEDLES CAN BE USED IN MRI ENVIRONMENT UNDER CERTAIN CIRCUMSTANCES. THE EXACT CONDITIONS ARE NOT WELL-UNDERSTOOD. PRODUCT ITSELF DID NOT MALFUNCTION. WE REGARD THIS AS AN INCOMPATIBILITY BETWEEN THE NEEDLES AND THE SPECIFIC CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946493 TECHNOMED EUROPE DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR GXZ TECHNOMED EUROPE TE/S46-638 045443 08718375861530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other