Technomed Europe TE/S46-638Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08718375862834), received between Dec 20, 2021 and Jul 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (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. Aug 9, 2022Class IITerminated

   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 ↗

Most reported problems

Recent adverse event reports

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

• 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 ↗