MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-09-18 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Lifesciences (ireland) Limited.
[3800323]
This is the third report of three involving a malfunction that occurred during a procedure on the same pt at the same facility (cross reference with mfr 3006697299-2013-00065 (b)(4) and mfr 3006697299-2013-00070 (b)(4)). The theatre reported of a 36khz handpiece getting very hot and the small of burning after only a few seconds of using. This blackened the end of the tip. They replaced all consumables; however, handpiece and tip still very very hot. Diathermy not working properly either. The machine was also making a high pitched screeching noise. The unit was in contact with a pt. The procedure was delayed an hour but, the pt did not incur an injury as a result of this event. The sales rep visited the account and performed a full check with and without the valleylab force fx nosecone attached to diathermy machine. The console, handpiece and tip were 100% serviceable. The sales rep also took advise from the engineer to ensure she completed all necessary checks. After 25 minutes of constant use the machine still continued to work perfectly.
Patient Sequence No: 1, Text Type: D, B5
[11282450]
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 | 3006697299-2013-00071 |
| MDR Report Key | 3394785 |
| Report Source | 01,05 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-08-16 |
| Date Mfgr Received | 2013-08-20 |
| Date Added to Maude | 2013-12-26 |
| 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 Country | US |
| 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 | 2013-09-18 |
| 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 LIFESCIENCES (IRELAND) LIMITED |
| Manufacturer Address | SRAGH, TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |