MAUDE Adverse Event Report: TECHNOMED EUROPE TECHNOMED EUROPE; DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR

Model Number	TE/S46-638
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TECHNOMED EUROPE
• Common Device Name: DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR
• Manufacturer (Section D): TECHNOMED EUROPE; amerikalaan 71; maastricht-airport, limburg 6199 AE; NL 6199 AE
• Manufacturer (Section G): TECHNOMED ASIA; k.i. trikencana kav. 4-5, jl.; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: sanne habets ; amerikalaan 71; maastricht-airport, limburg 6199 -AE ; NL 6199 AE
• MDR Report Key: 13041654
• Report Number: 9710376-2021-00004
• Device Sequence Number: 12118516
• Product Code: GXZ
• UDI-Device Identifier: 08718375861530
• UDI-Public: 08718375861530
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K990015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TE/S46-638
• Device Catalogue Number: TE/S46-638
• Device Lot Number: 045443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown