MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY DEVICE

Model Number	MST0809
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The revolve stereotactic probe is a sterile, single-patient use device that may be used with imaging guidance to excise a tissue sample for diagnosis.One mst0809 probe was received february 11, 2019 and evaluated february 22, 2019.The device was found to have cup alignment on the marker port during first sample by user; therefore, tissue did not transport into chamber one.Breast tissue was found in the cutter of the 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 sales, stating, during procedure no tissue was acquired.This is documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY DEVICE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8441927
• Report Number: 3008492462-2019-00014
• Device Sequence Number: 19087539
• Product Code: KNW
• UDI-Device Identifier: 10841911100710
• UDI-Public: (01)10841911100710(17)211030(10)F11843219D
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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: 10/30/2021
• Device Model Number: MST0809
• Device Catalogue Number: MST0809
• Device Lot Number: F11843219D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1