MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-04-25 for EXCEL 36KHZ CURVED EXTENDED PRECISION TIP BOX4 C4608S manufactured by Integra Lifesciences (ireland) Limited.
[3348852]
It was reported that the flue of the c4608s excel 36khz curved extended precision to is too high. The irrigation does not come out and goes directly in the preaspiration hoes. Nothing comes to the issue. They tried to pull the flue a bit more in direction of the tip. Then it works, but the visibility of the tip is bad and the irrigation comes out at the nosecone. (maybe a wrong flue is packed with the tip) surgery was a glioblastome and was delayed for 10 minutes. The unit was in contact with a pt but there was no injury.
Patient Sequence No: 1, Text Type: D, B5
[10825251]
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 | 3006697299-2013-00034 |
| MDR Report Key | 3085023 |
| Report Source | 01,05 |
| Date Received | 2013-04-25 |
| Date of Report | 2013-04-25 |
| Date Mfgr Received | 2013-04-04 |
| Date Added to Maude | 2013-06-28 |
| 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 CURVED EXTENDED PRECISION TIP BOX4 |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-04-25 |
| Catalog Number | C4608S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-04-25 |