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

Model Number	HH8BEX
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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 of diagnosis.The device has not been returned for investigation.No adverse event occurred with the usage of this product.Due to the open package that can potentially affect sterility, we consider this event to be a product malfunction that if it were to recur, has the potential to cause or contribute to a serious injury.Pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
It was reported by the (b)(6) affiliate that needles packing have varying degrees of breakage leakage.These needles are not opened and used.

• Brand Name: MAMMOTOME EX BIOPSY SYSTEM
• Common Device Name: BIOPSY DEVICE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7582629
• Report Number: 3008492462-2018-00045
• Device Sequence Number: 1980218
• Product Code: KNW
• UDI-Device Identifier: 00841911100959
• UDI-Public: (01)00841911100959(17)220622(10)F11808470D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 02/28/2023
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F11808470D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1