MAUDE Adverse Event Report: Devicor Medical Products Inc MammoMARK; MammoMARK Biopsy Site Identifier 8G - U-shape - Non-CE

Model Number	MMK0802
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during the procedure there was difficulty with the deployment of the marker, with the guide breaking while the needle was being removed.The marker and the orange part of the guide remained in the intra-mammary position.The procedure was not completed/stopped.No patient consequences.Complaint reported to authority.
Additional Manufacturer Narrative
According to the reporter, during the procedure there was difficulty with the deployment of the marker, with the guide breaking while the needle was being removed.The marker and the orange part of the guide remained in the intra-mammary position.The procedure was not completed/stopped.No patient consequences.Complaint reported to authority.After good faith efforts, it was determined that the tip shear remained in the breast and that there will be surgery for removal of cancer.Date of procedure is unknown.The device was not returned for evaluation.Based on available information and user feedback, the most likely root cause was determined to be customer failure to follow the instructions for use (ifu).The ifu clearly states: "caution: do not insert beyond appropriate band or tip damage may occur." "caution: do not activate the probe cutter or other clinical functions while a marker is inserted in the probe.Take care to completely remove the marker out of the probe before activating any of the holster's clinical functions." failure to adhere to these precautions may have contributed to the reported issue.If any new information becomes available, the complaint will be reassessed accordingly.

• Brand Name: MammoMARK
• Common Device Name: MammoMARK Biopsy Site Identifier 8G - U-shape - Non-CE
• Manufacturer (Section D): Devicor Medical Products Inc; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): Devicor Medical Products De Mexico; sor juanaines de la cruz; #20152 4-b; tijuana, bc 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241 ; +1(513)864-9047
• MDR Report Key: 50951016
• Report Number: 3008492462-2026-00016
• Device Sequence Number: 10446779
• Product Code: NEU
• UDI-Device Identifier: 00841911100485
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: MMK0802
• Device Catalogue Number: CA000151018
• Device Lot Number: F12610349D
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• 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: Unknown