MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMTOME REVOLVE ULTRASOUND PROBE; BIOPSY INSTRUMENT

Model Number	MHUS08
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mhus08 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 mhus08 was returned for investigation.Upon evaluation of the device, the cutter gear was found to be moving easily, not bound.Small specs of blood were found in multiple chambers of the sample management system, breast tissue found in the cutter.The cutter was cleared and the device retrieved 3/3 chicken samples.The device was determined to be conforming.If the tissue is found within the cutter 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)(6), stating "during the procedure, error message occurred and inner cutter of the probe stopped in the middle".This has been documented in our system as record # (b)(4).

• Brand Name: MAMMTOME REVOLVE ULTRASOUND 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: 8640017
• Report Number: 3008492462-2019-00026
• Device Sequence Number: 11324448
• Product Code: KNW
• UDI-Device Identifier: 10841911100819
• UDI-Public: (01)10841911100819(17)201016(10)F11741452D
• 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: 10/16/2020
• Device Model Number: MHUS08
• Device Catalogue Number: MHUS08
• Device Lot Number: F11741452D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• 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