BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNOMED EUROPE

    MDR report key: 23614921 · Received November 21, 2025

    Report

    Report Number
    9710376-2025-00002
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 21, 2025
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    IKT
    PMA / PMN Number
    K130136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEFINITIVE ROOT CAUSE CANNOT BE CONFIRMED AS THE IMPACTED DEVICE WAS DISPOSED OF. BASED ON THE GIVEN INFORMATION AND A REVIEW OF THE REATINED SAMPLES, THE MOST LIKELY ROOT CAUSE IS THAT THE COATING ON THE NEEDLE WAS NOT STRIPPED DURING THE MANUFACTURING PROCESS. A STATISITICAL ANALYSIS OF THE PULL FORCES BETWEEN THE NEEDLE AND THE LEAD WIRE FROM THE FINISHED GOOD INSPECTION DATA IN 2025 INDICATES THAT THE CHANCE OF FAILING THE 22N SPECIFICATION LIMIT IS LOW, WITH 1.55 PPM ((B)(4) FAILURE RATE). THE RESULTS INDICATE THAT THIS IS AN ISOLATED INCIDENT, NOT A SYSTEMIC ISSUE.

    Additional Manufacturer Narrative · 0

    WITHOUT HAVING ACCESS TO THE NEEDLE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. INVESTIGATION IS UNDERWAY TO EVALUATE POTENTIAL FAILURE MODES. THE FINISHED GOODS INSPECTION RECORDS FOR LOT 101304 DID NOT INDICATE ANY SYSTEMIC ISSUE, AND ALL PULL TESTING RESULTS WERE ABOVE SPECIFICATION. THE EVENT DESCRIBED INDICATES THAT THE NEEDLE WAS INSERTED IN THE PATIENT ALL THE WAY TO THE HUB, CONTRARY TO THE IFU. AVOIDING FULL INSERTION OF THE NEEDLE ENSURES THAT A SMALL PORTION IS OUTSIDE OF THE PATIENT IN CASE OF BREAKAGE/DETATCHMENT. INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CLOSURE OF THIS CASE.

    Description of Event or Problem · 0

    TECHNOMED RECEIVED EMAIL 27 OCT 2025 FROM BRAZILIAN REGISTRATION HOLDER NOTIFYING OF AN INCIDENT REPORTED TO ANVISA (NUMBER (B)(4)). A PHYSICIAN REPORTED A FAILURE RELATED TO THE MONOPOLAR NEEDLE DURING AN ELECTRONEUROMYOGRAPHY EXAMINATION. ACCORDING TO THE REPORT, DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM ITS BASE AND REMAINED IN THE PATIENT'S MUSCLE, SPECIFICALLY IN THE REGION OF THE TENSOR FASIAE LATAE MUSCLE. THE PATIENT EXPERIENCED PAIN ONLY, WITH NO SIGNS OF BLEEDING OR LOSS OF STRENGTH. THE PATIENT WAS REFERRED TO IMAGING AND REMOVAL AT ANOTHER FACILITY. SUBSEQUENT TESTING BY THE CLINIC SHOWED THAT ANOTHER ELECTRODE FROM THE SAME LOT COULD BE MANUALLY DETACHED WITH TWEEZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925620 TECHNOMED EUROPE DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, PRE-WIRED, TORCAR TIP IKT TECHNOMED EUROPE TE/AD3735-335/01 101304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other