MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUFLEX

Model Number	271641
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tuflex is intended as a preoperative marker of nonpalpable suspected breast lesions to facilitate the intraoperative localization of the findings by the surgeon.The tuflex consists of 19 twisted thin wires which guaranties a high flexibility.During the removal of a suspected breast lesion the surgeon touched the tuflex wire with the electrical cautery device several times.This resulted in a damage of the thin wires and some of them broke.The whole suspected tissue has been removed by the surgeon and during the following examination of the tissue the broken wires have been detected.No single wire fragments have been left in the patient.The entire wire (including fragments) were removed along with the specimen/lesion.No additional surgical intervention was necessary.In this case the patient was not damaged.The tuflex is a new marking wire with a high flexibility due to the 19 twisted thin wires.In the development phase of the product the possibility of contact between the thin wires and the electrical cauter device has not been considered.Caused by the fact that this incident could happen again with the tuflex wire, somatex decided to start a recall to prevent patients from any harm.
Event or Problem Description
During the removal of a suspected breast lesion the marking wire tuflex was tapped with a cautery device (bovie) and it splintered.

• Brand Name: TUFLEX
• Common Device Name: TUFLEX
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• MDR Report Key: 11228616
• Report Number: 1000408433-2021-00001
• Device Sequence Number: 19958789
• Product Code: MIJ
• UDI-Device Identifier: 04250195611574
• UDI-Public: 04250195611574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/26/2021
• Report Date (Section F): 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2025
• Device Model Number: 271641
• Device Catalogue Number: 271641
• Device Lot Number: 51269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1