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

Model Number	HH8BEX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2020
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.Although the device was not received, images from the event were reviewed and communication with the supplier confirmed that the malfunction was not caused due to a manufacturing problem but rather a handling issue that is causing the damage to the cutter.Actions have been put in place to improve the quality control of this device.There was no patient injury as a result of this event however, 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 before a procedure foreign material (small particles) found on the cutter.No patient consequences reported.This incident has been documented as complaint #: (b)(4).

• 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: 10889530
• Report Number: 3008492462-2020-00012
• Device Sequence Number: 3228821
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)250723(10)F12029530D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: KK033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2020

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: 07/23/2025
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F12029530D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1