MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME EX BIOPSY SYSTEM; BIOPSY INSTRUMENT

Model Number	HH8BEX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2019
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 excise a diagnostic sample from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.The device was returned to devicor for investigation.Upon evaluation the vacuum cartridge attached to the control module without issue and could not be removed without pressing the release feature.The probable cause for the vacuum cartridge disconnecting from the control module during the procedure was the user attached the cartridge upside down.Breast tissue was found in the collection chamber.Due to the discovery of breast tissue, this event was assessed against the result of the investigation.Following consultation with our medical director, due to the potential to cause or contribute to death or serious injury as a result 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
Devicor medical products, inc.Received a report from affiliate, devicor medical device (b)(4) co, ltd., stating, "during procedure, vacuum set cartridge connected to the capital loosely, and fell off easily.No patient consequences reported".This has been documented in our system as record #(b)(4).

• Brand Name: MAMMOTOME EX BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8767645
• Report Number: 3008492462-2019-00032
• Device Sequence Number: 2638412
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)240110(10)F11902315D
• Combination Product (Y/N): N
• PMA/510(K) Number: K033700
• 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): 07/08/2019

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: 01/10/2024
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F11902315D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1