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

Model Number	MST1012
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Set up vacuum assisted needle for biopsy and saline started pouring out of the connected tube to the device.Checked saline spike was not coming from there, looked like a leak where the connecter connects to the tube that saline runs through from the needle.

• 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: 23435704
• Report Number: 23435704
• Device Sequence Number: 20988932
• Product Code: KNW
• UDI-Device Identifier: 00841911102731
• UDI-Public: (01)00841911102731(10)F12528554D(17)280711
• 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): 10/07/2025
• Report Date (Section F): 10/07/2025

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
• Device Model Number: MST1012
• Device Catalogue Number: CA000399017
• Device Lot Number: F12528554D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/07/2025