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	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
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 device was not returned to devicor medical products, inc.For evaluation.Therefore we are unable to determine a root cause for the reported incident.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 a user facility stating, the probe took three attempts to latch to the holster.Latched after turning the thumb wheel and holding it down.During the procedure it did not collect tissue in the chamber but ended up putting the tissue into the canister.This has been 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: 8752367
• Report Number: 3008492462-2019-00030
• Device Sequence Number: 11189623
• Product Code: KNW
• UDI-Device Identifier: 00841911100713
• UDI-Public: (01)00841911100713(17)220411(10)F11915404D
• 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: user facility
• 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: 04/11/2022
• Device Model Number: MST0809
• Device Catalogue Number: MST0809
• Device Lot Number: F11915404D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• 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