MAUDE Adverse Event Report: SOMATEX Medical Technologies GmbH Tumark Professional X for Eviva Standard; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TUMARK-E13-S-X-02
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a breast biopsy procedure on (b)(6) 2026, using a tumark biopsy site marker, the "x marker was deployed, stereo picture was taken and marker was seen.Held pressure for 10 minutes and then took "[the]" patient to "[the]" mammo room for post pictures.Marker was not seen on cc or mlo pictures." additional information was obtained from the customer in which the customer denies the observation of heavy bleeding whereas the marker may have been inadvertently flushed out and reports that holding pressure at the site for 10 minutes "is our average pressure time." it is reported that the cannula, 4x4 gauze and surrounding areas were searched for the marker; however, it could not be located.No patient harm or additional interventions were reported.
Event or Problem Description
It was reported that during a breast biopsy procedure on april 30, 2026, using a tumark biopsy site marker, the "x marker was deployed, stereo picture was taken and marker was seen.Held pressure for 10 minutes and then took "[the]" patient to "[the]" mammo room for post pictures.Marker was not seen on cc or mlo pictures." additional information was obtained from the customer in which the customer denies the observation of heavy bleeding whereas the marker may have been inadvertently flushed out and reports that holding pressure at the site for 10 minutes "is our average pressure time." it is reported that the cannula, 4x4 gauze and surrounding areas were searched for the marker; however, it could not be located.No patient harm or additional interventions were reported.
Additional Manufacturer Narrative
An investigation was conducted: the customer provided images were analyzed by a hologic clinical application specialist.The image analysis determined that the device trocar is still visible in the customer provided image and the marker was most likely placed into the trocar.Therefore, upon removing the trocar, the marker was removed with it.This knowledge changes the result of the complaint investigation from "marker migration issue" to "user error".The user either used a shorter application system that is not compatible with the trocar length, or the user did not slide the application system all the way down to the end of the trocar to release the marker behind the trocar.In the ifu it is recommended to check the compatibility of the trocar length and the canula length of the application system.This complaint is considered not justified.

• Brand Name: Tumark Professional X 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: 25242335
• Report Number: 3030927217-2026-00003
• Device Sequence Number: 13387234
• Product Code: NEU
• UDI-Device Identifier: 04250195612069
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Model Number: TUMARK-E13-S-X-02
• Device Catalogue Number: TUMARK-E13-S-X-02
• Device Lot Number: 54103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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
• Patient Sex: Unknown