MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC 8G X 12 MAMMOTOME REVOLVE ULTRASOUND PROBE; BIOPSY SYSTEM, PRODUCT CODE: KNW

Model Number	MHUS08
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mamotome revolce dual vacuum assisted biopsy system is intended to obtain tissue samples from the breast or axillary 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 vacuum tubing 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 results 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
It was reported by affiliate during procedure the needle did not take the specimens, the preparations were in the suction tubes and in the needle path.After removing the needle from the breast, the doctor pushed the preparations through the place of application of the marker.Procedure was completed with another device.No patient complications.Record# (b)(4).

• Brand Name: 8G X 12 MAMMOTOME REVOLVE ULTRASOUND PROBE
• Common Device Name: BIOPSY SYSTEM, PRODUCT CODE: KNW
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e-business way; fifth floor; cincicinnati OH 45241
• MDR Report Key: 9132513
• Report Number: 3008492462-2019-00044
• Device Sequence Number: 11559619
• Product Code: KNW
• UDI-Device Identifier: 00841911100812
• UDI-Public: (01)00841911100812(17)220429(10)F11917470D
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 04/29/2022
• Device Model Number: MHUS08
• Device Catalogue Number: MHUS08
• Device Lot Number: F11917470D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1