MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOMARK; BIOPSY SITE IDENTIFIER

Model Number	MAM3001
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges.As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement.
Event or Problem Description
Devicor medical products, inc.Received a report from user facility, stating, tip shear occurred during stereo biopsy.Doctor left in the breast because they are waiting to see if patient will go to surgery once pathology report comes back.Doctor pulled marker out of the probe instead of removing the probe/marker as one unit.This has been documented in our system as record #(b)(4).

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8854930
• Report Number: 3008492462-2019-00039
• Device Sequence Number: 16711188
• Product Code: NEU
• UDI-Device Identifier: 10841911101595
• UDI-Public: (01)10841911101595(17)200221(10)F11833475D
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Device Lot Number: F11833475D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1