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

Model Number MAM3008

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to mark 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 Description

Devicor medical products, inc.Received a report by sales representative of a mam3008 tip shear during a procedure.Tip of deployment device cut off in patient.This has been documented in our system as record #(b)(4).

• Brand Name: MAMMOMARK
• Type of Device: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, 22440 ; MX 22440
• Manufacturer Contact: jack cummings ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 9679771
• MDR Text Key: 197600264
• Report Number: 3008492462-2020-00002
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911101659
• UDI-Public: (01)00841911101659(17)201219(10)F11924449D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F11924449D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention