MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-01-02 for UNKNOWN CUSA EXCEL XXX-CUSA manufactured by Integra Lifesciences (ireland) Limited.
[3109443]
A "default" was reported with a cusa excel console which was smoking/smell of smoke coming from the console. The footswitch plug is also damaged. The unit was in contact with a patient however, there was no injury involved and there was no surgical delay as a result. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10465051]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2012-00052 |
| MDR Report Key | 2899690 |
| Report Source | 01,05 |
| Date Received | 2013-01-02 |
| Date of Report | 2013-01-02 |
| Date of Event | 2012-12-11 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-03-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CUSA EXCEL |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-01-02 |
| Catalog Number | XXX-CUSA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
| Manufacturer Address | SRAGH TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-02 |