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Technomed Europe TE/S50715-001Recalls & reported problems

Technomed Engineering B.V. · Disposable Subdermal Needle Electrode, corkscrew, 4 x 6 colors, 1.2m wire · Class 2

All models of Technomed Europe (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08718375863442), received between Nov 15, 2021 and Dec 10, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Dec 8, 2021Class IITerminated

    There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

    Z-0465-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Separation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 10, 2021Material Separation; Material Separation

    THE PROBLEM OCCURRED WITH THE SECOND CORKSCREW THEY USED DURING THE PROCEDURE, THE FIRST ONE WENT FINE. THE USER INSERTED IT A HALF TURN, BUT IT COULD NOT BE INSERTED COMPLETELY INTO THE SKIN AS THE HUB STARTED TURNING. SHE HAD NO GRIP ON THE NEEDLE ANYMORE. THEN, SHE TRIED TO PULL IT OUT, BUT THE NEEDLE DID NOT COME OUT DUE TO LACK OF GRIP BECAUSE OF THE LOOSE HUB. THE SURGEON WAS IN A HURRY, WHICH IS WHY THEY PLACED A NEW CORKSCREW AND LEFT THE DEFECTIVE ONE AS IS. AFTER THE SURGERY, THE SURGEON USED A LITTLE SURGICAL INSTRUMENT (FORCEPS) TO REMOVE THE NEEDLE. 1MM AT A TIME, HE PULLED IT OUT. THE PATIENT BLED QUITE A LOT AFTER THE NEEDLE CAME OUT. THE NEEDLE WAS STILL ATTACHED TO THE LEAD WIRE. DUE TO USING PRESSURE, THE NEEDLE WAS DEFORMED. THE WOUND WAS STAUNCHED AND BLEEDING STOPPED AFTER A WHILE. NO STITCHING WAS NECESSARY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12974279 ↗
  • InjuryNov 15, 2021Material Separation; Material Separation

    THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12811651 ↗

Other Electrode, Needle, Diagnostic Electromyograph devices

All Electrode, Needle, Diagnostic Electromyograph devices →

Sources and updates

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