RHOTON HOOK, ANGLED 90 DEGREES BLUNT NL3185-010 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-10 for RHOTON HOOK, ANGLED 90 DEGREES BLUNT NL3185-010 * manufactured by Carefusion.

Event Text Entries

[3473409] The tip of nerve hook instrument broke off and fell into the patient's heart during a valve replacement surgery. Attempts to find it with magnet unsuccessful. X-ray of patient did not reveal where tip was at. X-ray done of cell saver and heart bypass filters. The tip was found in the cell saver filter. What was the original intended procedure? Heart valve replacement. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3207145
• MDR Report Key: 3207145
• Date Received: 2013-06-10
• Date of Report: 2013-06-10
• Date of Event: 2013-05-31
• Report Date: 2013-06-10
• Date Reported to FDA: 2013-06-10
• Date Reported to Mfgr: 2013-07-05
• Date Added to Maude: 2013-07-05
• 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
• Reporter Occupation: RISK MANAGER
• 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: RHOTON HOOK, ANGLED 90 DEGREES BLUNT
• Generic Name: INSTRUMENT, MICROSURGICAL
• Product Code: GZX
• Date Received: 2013-06-10
• Model Number: NL3185-010
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 22 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAREFUSION
• Manufacturer Address: 1500 WAUKEGAN RD. WAUKEGAN IL 60085 US 60085

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-10