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

Model Number	HH11BEX
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2017
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 for 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
The (b)(4) affiliate reported that when staff took out the set from the box, the packaging was torn.
Additional Manufacturer Narrative
One hh11bex probe from lot# f11710453d was received on october 19, 2017 and evaluated on november 6, 2017.Device package integrity was found to be compromised.The top of the sterile package was found to have 2 cuts.One approximately 1.75 inches in length and the second to be approximately 1.25 inches.The condition of the shipping box is unknown.This lot was 100% inspected and released from inspection on april 6, 2017 and found to have no visual defects.Product was shipped to the customer on april 2, 2017 and delivered on april 29, 2017.The device carton as well as the shipper box were not returned for analysis thus preventing a determination of root cause.Date of report was updated with the date the mew information was received.Type of report was updated to indicate this is a follow-up report.Device evaluated by mfr was udated to indicated the device had been evaluated.(b)(4).
Event or Problem Description
The (b)(6) affiliate reported that when staff took out the set from the box, the packaging was torn.

• 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: 6744523
• Report Number: 3008492462-2017-00048
• Device Sequence Number: 13764054
• Product Code: KNW
• UDI-Device Identifier: 00841911100942
• UDI-Public: (01)00841911100942(17)220315(10)F11710453D
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: No Information
• Device Expiration Date: 03/15/2022
• Device Model Number: HH11BEX
• Device Catalogue Number: HH11BEX
• Device Lot Number: F11710453D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1