MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME EX BIOPSY SYSTEM

Model Number	HH8BEX
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mammotome ex probe is a sterile, single patient use instrument that may be used with imaging guidance, such as ultrasound, to exercise a diagnostic sample from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.Device has not been returned to devicor medical products, inc.Therefore device evaluation could not be performed.We are submitting this medwatch report pursuant to 21 cfr 803- if the malfunction were to re-occur, it would be likely to cause or contribute to death or serious injury.
Event or Problem Description
It was reported by the affiliate that during the procedure , a very hard foreign matter was observed in the tissues during procedure.Procedure was completed using device with no patient complications.This has been documented in our system as record number (b)(6).

• Brand Name: MAMMOTOME EX BIOPSY SYSTEM
• Common Device Name: MAMMOTOME EX BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 9579349
• Report Number: 3008492462-2020-00001
• Device Sequence Number: 16860655
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)240718(10)F11928535D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: KK033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: 07/18/2024
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F11928535D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1