NEOPROBE NEOPROBE2000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-11 for NEOPROBE NEOPROBE2000 * manufactured by Mammotome, A Division Of Devicor Medical Products, Inc..

Event Text Entries

[19727092] Neoprobe 2000 gamma detection system was found out to be not working properly. There was an error code appearing on the screen that the expected normal number that was to appear on the screen wasn't seen. Md operated the equipment. Clinical engineering notified. Nuclear medicine was called and checked the equipment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2954004
• MDR Report Key: 2954004
• Date Received: 2013-01-11
• Date of Report: 2013-01-11
• Date of Event: 2013-01-08
• Report Date: 2013-01-11
• Date Reported to FDA: 2013-01-11
• Date Reported to Mfgr: 2013-02-11
• Date Added to Maude: 2013-02-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEOPROBE
• Generic Name: COUNTER (BETA, GAMMA) FOR CLINICAL USE
• Product Code: IZD
• Date Received: 2013-01-11
• Model Number: NEOPROBE2000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAMMOTOME, A DIVISION OF DEVICOR MEDICAL PRODUCTS, INC.
• Manufacturer Address: 300 E BUSINESS WAY CINCINNATI OH 45241 US 45241

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-01-11