MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE; INSTRUMENT, BIOPSY

Model Number	MST1012
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty needle for biopsy needle would not lock to machine needle holder.

• Brand Name: MAMMOTOME REVOLVE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 24531718
• Report Number: 24531718
• Device Sequence Number: 16036681
• Product Code: KNW
• UDI-Device Identifier: 00841911102731
• UDI-Public: (01)00841911102731
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/02/2026

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: MST1012
• Device Catalogue Number: CA000399017
• Device Lot Number: F12528554D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/02/2026