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
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: 11250305
• Report Number: 3016567401-2021-00001
• Device Sequence Number: 19654684
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1