MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK® VISION FOR EVIVA® STANDARD; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TUMARK-E13-S-VISION
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that during an vacuum assisted excision of a b3 lesion on (b)(6) 2025, the lesion contained a tumark ¨vision¨breast marker.The vacuum assisted excision was performed using a 7g bd encore device.The facility reported that the marker was damaged during the procedure and several small fragments were lodged within the surrounding breast tissue.No other information was provided.

• Brand Name: TUMARK® VISION FOR EVIVA® STANDARD
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23865831
• Report Number: 3030927217-2025-00001
• Device Sequence Number: 20165786
• Product Code: NEU
• UDI-Device Identifier: 04250195611222
• UDI-Public: 04250195611222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: TUMARK-E13-S-VISION
• Device Catalogue Number: TUMARK-E13-S-VISION
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female