MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE STEREOTACTIC PROBE - 10G; 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	05/03/2019
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.The probe was returned to devicor for evaluation.The device was received with blood in the cup and on chamber four.Initial attempt to take samples of chicken breast test medium was unsuccessful.The device was biopsied in water to clear the dried blood.A small piece of breast tissue was found.Following the clearing of the dried blood and tissue, the probe successfully obtained samples of the chicken breast test medium.The device was disassembled and no abnormalities were found.Probable root cause for the device not obtaining samples was the clogged probe.Due to the discovery of the tissue, this event was assessed against the result of the investigation.Following consultation 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 mode was determined to be a reportable malfunction.
Event or Problem Description
Devicor medical products, inc.Received a report from a user facility stating, during the procedure the 10g probe didn't get any samples.No patient complications.This has been documented in our system as report #(b)(4).

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE - 10G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8752599
• Report Number: 3008492462-2019-00031
• Device Sequence Number: 1669147
• Product Code: KNW
• UDI-Device Identifier: 10841911100741
• UDI-Public: (01)10841911100741(17)220128(10)F11904574D
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F11904574D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1