MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOTOME SYSTEM CONTROL MODULE; BIOPSY SYSTEM

Model Number	SCM12
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mammotome biopsy system is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.The device was returned to the manufacturer on (b)(6) 2018 and analyzed on (b)(6) 2018.The voc was not confirmed.However, components, including bezel, main housing, tuving bulhead gasket, bezel rope gasket, muffler, lazy susan, display pivot bracket, resistance fingers, and rubber washers replaced due to service bulletins and general preventive maintenance.Additionally, the interface circuit board was observed to be damaged, which could be likely cause of the reported smell.The interface circuit board was replaced.The device was functionally tested and passed, confirm suitability for use.The device was returned to the customer for continued use.Although there was no patient consequence, due to the remote potential of this malfunction to cause or contribute to death or serious injury as a result of a potential device fire, this event was determined to be mdr reportable pursuant to 21 cfr 803.
Event or Problem Description
It was reported by the sales rep that before the procedure the blue connector cable will not fit into port properly and unit is giving off a burning smell with several error codes.The procedure was stopped and not completed.No patient consequence.

• Brand Name: MAMMOTOME SYSTEM CONTROL MODULE
• Common Device Name: BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7654717
• Report Number: 3008492462-2018-00048
• Device Sequence Number: 10794551
• Product Code: KNW
• UDI-Device Identifier: 00841911100591
• UDI-Public: (01)00841911100591(11)080729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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 Model Number: SCM12
• Device Catalogue Number: SCM12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1