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

Model Number	MST1009
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
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.If the tissue is found within the canister rather than in the sample managment systems, a misdiagnosis is possible due to lost tissue.Following consulatation with our medical director, due to the potential to cause or contribute to death or serious injury as a result of potential missed or lost tissue samples, pursuant to 21 cfr 803, this failure was determined to be a reportable malfunction.
Event or Problem Description
Devicor medical products, inc.Received a report from our affiliate, devicor medical (b)(6) stating that "tissue samples bypassed the collection cup and went straight into the canister.After the procedure, when they checked the canister, there was a lot of adipose tissues.Also they found a calcified tissue in it.No patient complications." this has been documented in our system as record # (b)(4).

• 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 45241
• MDR Report Key: 9159416
• Report Number: 3008492462-2019-00046
• Device Sequence Number: 1801277
• Product Code: KNW
• UDI-Device Identifier: 00841911100744
• UDI-Public: (01)00841911100744(17)220409(10)F11914472D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: No Information
• Device Expiration Date: 04/09/2022
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F11914472D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1