MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-14 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Lifesciences. Ltd.
[3306522]
During surgery due to craniotomy for tumor removal a (c2602) 36 khz hand piece was reported to have become excessively "hot". The problem with the handpiece resulted in no pt or user harm or incident. The doctor using it simply complained it was excessively hot or hotter than normal. Everything went fine with the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10350885]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2013-00005 |
| MDR Report Key | 2919851 |
| Report Source | 05 |
| Date Received | 2013-01-14 |
| Date of Report | 2013-01-14 |
| Date of Event | 2012-12-27 |
| Date Mfgr Received | 2012-12-27 |
| Date Added to Maude | 2013-04-04 |
| 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 DRIVE |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-01-14 |
| Catalog Number | C2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES. LTD |
| Manufacturer Address | ANDOVER HAMPSHIRE SP104DR UK SP104DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-14 |