MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTEST, BIOPSY TABLE; MAMMOGRAPHY TABLE

Model Number MMT100

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The mammotome mammotest system is used for minimally invasive breast biopsy procedures.The system uses x-ray guidance for stereotactic localization, allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern.Devicor field service engineer evaluated the device and found the cause of the burning smell to be related to capacity on 24v power card.Excessive current draw from a short circuit; 24v to ground.It is not likely that this short circuit would have led to a fire in the device.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 remote potential of device fire, this has been determined to be reportable pursuant to 21 cfr 803.

Event Description

Devicor medical products received a report from affiliate stating, the generator is heated up and smells like something is burning.This has been documented in our complaint system as record (b)(4).

• Brand Name: MAMMOTEST, BIOPSY TABLE
• Type of Device: MAMMOGRAPHY TABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS INC.; 300 e. business way; cincinnati OH 45241
• Manufacturer Contact: jill burnett ; 300 e. business way; cincinnati, OH 45241 ; 5138649047
• MDR Report Key: 7984814
• MDR Text Key: 126110370
• Report Number: 3008492462-2018-00066
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• PMA/PMN Number: K042095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MMT100
• Device Catalogue Number: MMT100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1