MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-02-27 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Neurosciences Ltd.
[3256317]
Initially it was reported that a cusa hand piece 36khz leaked during a procedure. On (b)(6) 2013, additional info was received, and was described as follows: the unit was dripping fluid during an acoustic neuroma procedure however, the unit was not in contact with the pt. The pt was anesthetized and there was a delay of 20 minutes while another hand piece was located and setup. The nurse did report however, that in essence there was no delay because the surgeon continued to perform the procedure until the other hand piece was ready for use. She was unable to provide pt demographics or the date of the event.
Patient Sequence No: 1, Text Type: D, B5
[10591603]
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 | 3006697299-2013-00014 |
| MDR Report Key | 3023121 |
| Report Source | 99 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-02-27 |
| Date Mfgr Received | 2013-02-13 |
| Date Added to Maude | 2013-05-08 |
| 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 | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-02-27 |
| Catalog Number | C2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-02-27 |