MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-04 for EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Neurosciences, Ltd..
[16059805]
The first report of two involving a 36 khz handpiece. A 36khz cusa handpiece got very hot during use. The first handpiece completely stopped working. The unit was in use 2-3 minutes when the problem occurred. The settings were 100 aspiration, 100 amplitude, 3 ml/minute. The surgery was not delayed as a result of this issue. Did the surgeon or pt did not incur an injury as a result of this problem.
Patient Sequence No: 1, Text Type: D, B5
[16386322]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2014-00009 |
| MDR Report Key | 3753416 |
| Report Source | 05 |
| Date Received | 2014-02-04 |
| Date of Report | 2014-01-10 |
| Date of Event | 2014-01-03 |
| Date Mfgr Received | 2014-01-10 |
| Date Added to Maude | 2014-05-13 |
| 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 | EXCEL 36KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-02-04 |
| Catalog Number | C2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES, LTD. |
| Manufacturer Address | ANDOVER HAMPSHIRE SP104DR UK SP104DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-04 |