MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY SYSTEM

Model Number	MST0809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mammotome revolve dual vacuum assisted biopsy system is intended to obtain tissue samples from the breast or axillary nodes for diagnosic analysis of breast abnormalities.Images provided did not contain information that could confirm what caused the alledged failure.The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time.Patient did not undergo any additional surgery, however, due to the allegation of foreign material we are submitting this medwatch report pursuant to 21 cfr 803.
Event or Problem Description
It was reported by sales rep during procedure, fragments left in breast after firing and biopsy.This incident has been documented as complaint # (b)(4).

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 11276874
• Report Number: 3008492462-2021-00001
• Device Sequence Number: 3692118
• Product Code: KNW
• UDI-Device Identifier: 00841911102564
• UDI-Public: (01)00841911102564(17)231109(10)F12045233D
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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 Expiration Date: 11/09/2023
• Device Model Number: MST0809
• Device Catalogue Number: MST0809
• Device Lot Number: F12045233D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1