Technomed EuropeRecalls & reported problems across all models

We found 9 models of Technomed Europe by Technomed Engineering B.V. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2021 and Sep 30, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (2 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Technomed Europe recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 9, 2022Terminated

   Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.

   Z-1737-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Dec 8, 2021Terminated

   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 · names 7 of these models · Recall details · FDA record ↗

Most reported Technomed Europe problems

Technomed Europe models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Technomed Europe TE/S46-638

  Electrode, Needle, Diagnostic Electromyograph
  1 recall2 reports
• Technomed Europe TE/S50715-001

  Electrode, Needle, Diagnostic Electromyograph
  1 recall2 reports
• Technomed Europe TE/S50715-004

  Electrode, Needle, Diagnostic Electromyograph
  1 recall0 reports
• Technomed Europe TE/S50715-002

  Electrode, Needle
  1 recall0 reports
• Technomed Europe TE/S50715-003

  Electrode, Needle
  1 recall0 reports
• Technomed Europe TE/S50725-002

  Electrode, Needle
  1 recall0 reports
• Technomed Europe TE/S50715-001-C

  Electrode, Needle, Diagnostic Electromyograph
  1 recall0 reports
• Technomed Europe TE/S50725-002-C

  Electrode, Needle
  1 recall0 reports
• Technomed Europe MP214-3.0/1

  Electrode, Needle
  1 report

Recent Technomed Europe adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Component Missing

  WHEN REMOVING PROBE FROM METAL SHEATH, DR NOTICED THE PROBE SHEATH WAS MISSING. ALL PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15527699 ↗
• InjuryJul 25, 2022Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  COMPLAINT DESCRIPTION AS IN E-MAIL FROM INOMED (12TH OF JULY): "WE HAVE BEEN INFORMED BY ONE OF OUR TRADERS THAT A CUSTOMER HAS REPORTED AN INCIDENT WITH AN SDN ELECTRODE TO THE COMPETENT SPANISH AUTHORITY. AT THE MOMENT, WE DO NOT HAVE MORE DETAILED INFORMATION ABOUT THE SERIAL NUMBER AND THE BACKGROUND OF THE INCIDENT, NOR DO WE HAVE THE INITIAL REPORT TO THE AUTHORITIES. IT SEEMS THAT BURNS OCCURRED DURING USE." FURTHER INFORMATION RECEIVED VIA INOMED FROM END USER (18TH OF JULY 2022): THERE WAS NO EQUIPMENT MALFUNCTION. ELECTROCAUTERY WAS USED. THE PRODUCT WAS USED FOR STIMULATION AND SIGNAL ACQUISITION PURPOSES. THE ELECTRODES WERE KEPT IN THE PATIENT WHILE THE PATIENT WAS IN THE MR COIL. NEUROPHYSIOLOGICAL MONITORING WAS PERFORMED OUTSIDE THE MR COIL (MRI MACHINE USED: PHILLIPS INGENIA 1.5 T. REF. 84313). EXPERIENCE OF USERS: NEUROSURGICAL INTERVENTIONS WITH INTRAOPERATIVE MONITORING HAVE BEEN PERFORMED IN OUR CENTER FOR THE LAST 3 YEARS BY THE SAME TEAM, MANY OF THEM WITH NEUROPHYSIOLOGICAL INTRAOPERATIVE MONITORING. ONE PATIENT WAS INVOLVED. THE BURNS WERE FIRST DEGREE BURNS (LONG TERM TISSUE DAMAGE IS RARE). NO FURTHER INTERVENTION WAS NEEDED TO TREAT THE BURNS. PATIENT WA

  Patient problems: Burn(s)

  MAUDE report 15091862 ↗
• InjuryDec 20, 2021Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  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

  Patient problems: Burn(s)

  MAUDE report 13041654 ↗
• 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 Technomed Engineering B.V. products

• Neurosign V43 models · 2 reports · 1 recall