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.
[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
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 |
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 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-06-10 |