MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOTOME REVOLVE ULTRASOUND BIOPSY 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	05/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revolve ultrasound probe is a sterile, single-patient device that may be used with imaging guidance to excise a tissue sample for diagnosis.One mhus08 probe lot number f11729464d was returned for evaluation.Breast tissue was found in the sample cup upon receipt.The device initialized and using chicken breast as a medium, the device was able to obtain samples.The device was disassembled for evaluation and no "anomolies" were noted.The device was determined to be a conforming device.The initial voice of the customer received on 6/04/2018 was deemed not reportable as no patient consequence was noted.However, due to the discovery of the tissue, during the device evaluation on 12/14/2018, this event was reassessed for reportability 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 the affiliate stating, " in the sample mode, breast tissue could not be taken.User pressed the sample button; breast tissue could not be taken and the suction function was activated and 3-way valve opened and saline was injected with a syringe but breast tissue sample not held in chamber.Procedure was completed with another probe with no patient consequence".This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME REVOLVE ULTRASOUND BIOPSY 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: 8196472
• Report Number: 3008492462-2018-00086
• Device Sequence Number: 16557380
• Product Code: KNW
• UDI-Device Identifier: 00841911100812
• UDI-Public: (01)00841911100812(17)200726(10)F11729464D
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MHUS08
• Device Catalogue Number: MHUS08
• Device Lot Number: F11729464D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1