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

Model Number	MRP08S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During mri-guided breast biopsy, the mammotome bladeless probe with tube set failed to biopsy during procedure and had to be replaced with another set to complete procedure.No harm to patient.

• Brand Name: MAMMOTOME MR
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 east business way fifth floor; cincinnati OH 45241
• MDR Report Key: 12511956
• Report Number: 12511956
• Device Sequence Number: 20120387
• Product Code: KNW
• UDI-Device Identifier: 00841911101000
• UDI-Public: (01)00841911101000(17)260215(10)F12115313D
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• Report Date (Section F): 09/21/2021

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: MRP08S
• Device Lot Number: F12115313D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/21/2021