MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-20 for V. MUELLER ANGLED COTTLE SPRING SCISSOR * RH1701 manufactured by Carefusion 2200, Inc..
[4401513]
Patient undergoing endoscopic frontal sinusotomy. During the surgical procedure, the end of the angled cottle spring scissor broke off into the patient's nose. The broken piece was retrieved by the surgeon and inspected to ensure all of the instrument was retrieved.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3831952 |
MDR Report Key | 3831952 |
Date Received | 2014-05-20 |
Date of Report | 2014-05-20 |
Date of Event | 2014-05-15 |
Report Date | 2014-05-20 |
Date Reported to FDA | 2014-05-20 |
Date Reported to Mfgr | 2014-05-27 |
Date Added to Maude | 2014-05-27 |
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 | 0 |
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 | V. MUELLER ANGLED COTTLE SPRING SCISSOR |
Generic Name | SCISSORS, NASAL |
Product Code | KBD |
Date Received | 2014-05-20 |
Model Number | * |
Catalog Number | RH1701 |
Lot Number | XTA1 |
ID Number | * |
Operator | PHYSICIAN |
Device Availability | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CAREFUSION 2200, INC. |
Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-05-20 |