MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUFLEX

Model Number 271641

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Event 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
• Type of Device: TUFLEX
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• MDR Report Key: 11250305
• MDR Text Key: 229479230
• Report Number: 3016567401-2021-00001
• Device Sequence Number: 1
• Product Code: MIJ
• UDI-Device Identifier: 04250195611574
• UDI-Public: 04250195611574
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/31/2020,01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1