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

Model Number	HH8BEX
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
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 returned for further evaluation, images from the event were reviewed by a cross functional team and the root cause was inconclusive.There was no evidence that the alleged foreign material seen in the patient tissue samples came from the device or its packaging.There was no patient injury as a result of this event.
Event or Problem Description
It was reported by the affiliate that black material was found mixed in the tissue samples retrieved from the patient.No patient consequences reported.

• 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: 11600505
• Report Number: 3008492462-2021-00004
• Device Sequence Number: 3280154
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)250817(10)F12032635D
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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 Expiration Date: 08/17/2025
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F12032635D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1