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	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to attach stereotactic biopsy needle to holder to perform biopsy.Gear on needle appears to be broken/faulty.

• 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: 22435841
• Report Number: 22435841
• Device Sequence Number: 3201131
• Product Code: KNW
• UDI-Device Identifier: 00841911102731
• UDI-Public: (01)00841911102731(10)F12524408D(17)280617
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025
• Report Date (Section F): 07/02/2025

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: Other
• Device Model Number: MST1012
• Device Catalogue Number: CA000399017
• Device Lot Number: F12524408D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/02/2025