MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-01-31 for CUSA EXCEL 23KHZ STRAIGHT HANDPIECE C2600 manufactured by Integra Lifesciences (ireland) Limited.
[16775243]
It was reported that the handpiece was cracked and it did not connect to the cusa. There was no patient contact, no patient injury, no revision/medical intervention required; and no delay in surgery. Multiple request for additional information has been sent but to date, no new information has been received.
Patient Sequence No: 1, Text Type: D, B5
[16967534]
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 | 3006697299-2014-00007 |
| MDR Report Key | 3736487 |
| Report Source | 08 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-15 |
| Date Mfgr Received | 2014-01-15 |
| Date Added to Maude | 2014-05-07 |
| 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 | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 23KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-01-31 |
| Catalog Number | C2600 |
| 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 OFFLAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-31 |