MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-08-26 for COTTLE SEPTUM SCISSORS ANG SERR 6-7/8IN RH1701 manufactured by Carefusion.
[4803634]
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.? The lot number provided was "xta1", which is not a valid lot number.
Patient Sequence No: 1, Text Type: D, B5
[12008582]
(b)(4). The reported issue was identified by carefusion during a review of the fda maude database for all voluntary and user facility mdr reports submitted. This complaint (b)(4) was opened by carefuson to document this reported issue. The maude report does not contain customer contact information. Therefore, carefusion cannot send notification to the customer or obtain additional information regarding the reported incident. In addition, the lot number is unknown and the actual device is not available for evaluation. Therefore, an investigation and root cause analysis cannot be performed by carefusion. The complaint will be reopened and the reported issue investigated should additional information become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2014-00019 |
| MDR Report Key | 4037924 |
| Report Source | * |
| Date Received | 2014-08-26 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-05-20 |
| Date Mfgr Received | 2014-07-28 |
| Date Added to Maude | 2014-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTLE SEPTUM SCISSORS ANG SERR 6-7/8IN |
| Generic Name | SCISSORS, NASAL |
| Product Code | KBD |
| Date Received | 2014-08-26 |
| Model Number | RH1701 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-26 |