MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-11-13 for UCSA EXCEL 36KHZ CURVED EXTENDED PRECISION TIP C4608S manufactured by Integra Lifesciences Ireland Limited.
[2983957]
During a tumor resection a 36 khz hand piece with a curved extended precision tip that was used in combination with a cem nose cone for coagulation. During the procedure it was reported that two tips melted and were broken at the end of the tip. This event caused a twenty minute increase in surgery time. The pt was not injured.
Patient Sequence No: 1, Text Type: D, B5
[10338699]
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 | 3006697299-2012-00047 |
| MDR Report Key | 2852416 |
| Report Source | 01,08 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-10-22 |
| Date Mfgr Received | 2012-10-23 |
| Date Added to Maude | 2013-02-21 |
| 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 |
| Manufacturer Phone | 6099365560 |
| Manufacturer G1 | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Street | IDA BUSINESS AND TECHNOLOGY PARK |
| Manufacturer City | SRAGH TULLAMORE 0000 |
| Manufacturer Postal Code | 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UCSA EXCEL 36KHZ CURVED EXTENDED PRECISION TIP |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS. |
| Product Code | LBK |
| Date Received | 2012-11-13 |
| Catalog Number | C4608S |
| Lot Number | 1120859 |
| 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 | IDA BUSINESS AND TECHNOLOGY PARK SRAGH TULLAMORE 0000 EI 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-13 |