MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE STEREOTACTIC 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	04/23/2019
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.One mst1009 probe was received for investigation.Upon evaluation of the device, the sms cup is between chamber 10 and 11.It is likely that the sms cup was aligned on the marker chamber during the first sample, and therefore, the first sample went to the cannister.If the tissue is found within the canister rather than in the sample management system, a misdiagnosis is possible due to lost tissue.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 our affiliate, devicor medical (b)(4), stating the user acquired 6 tissue samples, but there were only 5 samples in the sms (sample management system) and then they found a tissue sample in the canister.This sample has many calcifications and the user believes that it is first sample.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC 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: 8641263
• Report Number: 3008492462-2019-00023
• Device Sequence Number: 16616723
• Product Code: KNW
• UDI-Device Identifier: 00841911100744
• UDI-Public: (01)00841911100744(17)211206(10)F11849404D
• Combination Product (Y/N): N
• 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): 05/24/2019

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: 12/06/2021
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F11849404D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1