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

Model Number	MST1009
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mst1009 probes are sterile, single use devices, indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.It was reported by sales rep that after successful biopsy with st modality there were curly, string like, opaque, tiny, short, threadlike artifacts seen in the specimen film.This incident has been recorded in complaint #(b)(4).Evaluation of the returned device did not display any damage and simulated biopsys did not contain any foreign material.Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the specimen film this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.
Event or Problem Description
It was reported by sales rep that after successful biopsy with st modality there were curly, string like, opaque, tiny, short, threadlike artifacts seen in the specimen film.This incident has been recorded in complaint #(b)(4).Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the specimen film this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.

• Brand Name: MAMMOTOME REVOLVE STEROTACTIC PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati, oh
• MDR Report Key: 9965875
• Report Number: 3008492462-2020-00007
• Device Sequence Number: 2092967
• Product Code: KNW
• UDI-Device Identifier: 10841911100741
• UDI-Public: (01)10841911100741(17)230107(10)F12001552D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F12001552D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention