MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-11-16 for EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 C2602 manufactured by Integra Lifesciences Ireland Limited.
[3003343]
The device, a excel 36khz straight handpiece became faulty and was not performing within the specification. The device was in contact with the patient however, the patient was not injured or was death alleged. The event led to increase the surgery time (unknown for how long). The handpieces are new and recently received with the new cusa consoles the customer ordered.
Patient Sequence No: 1, Text Type: D, B5
[10296107]
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 | 3006697299-2012-00048 |
| MDR Report Key | 2845269 |
| Report Source | 01,06 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-11-16 |
| Date Mfgr Received | 2012-10-25 |
| Date Added to Maude | 2013-02-25 |
| 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 | EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2012-11-16 |
| 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 LIFESCIENCES IRELAND LIMITED |
| Manufacturer Address | SRAGH TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |