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	10/08/2019
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.Device evaluation is anticipated, however, devicor medical products, inc.Has not yet received the device for evaluation.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
Devicor medical products, inc.Received a report stating the knockout tip fell off during procedure.The broken knockout tip almost got into the patient through the steel tube.This has been documented in our system as record number 11523686.

• 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: 9331723
• Report Number: 3008492462-2019-00050
• Device Sequence Number: 11417079
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)240710(10)F11927410D
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: No Information
• Device Expiration Date: 07/10/2024
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F11927410D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention