MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-04-15 for CUSA EXCEL 23KHZ CEM NOSECONE C6623 manufactured by Integra Lifesciences (ireland) Limited.
[3266840]
Case #4 from the same distributor involved a cusa excel 23khz cem nosecone (lot number 1115499) activated after one hour of use even though the button for activating the unit had not been pressed. The unit could not be deactivated. The setting was 60-70% power during a liver resection. There was no injury reported. There was no delay as the staff was able to use another unit to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10729193]
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 | 3006697299-2013-00024 |
| MDR Report Key | 3070115 |
| Report Source | 01,08 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-02-25 |
| Date Mfgr Received | 2013-03-28 |
| Date Added to Maude | 2013-06-19 |
| 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 | CUSA EXCEL 23KHZ CEM NOSECONE |
| Generic Name | ULTRASONIC SURGICLA PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-04-15 |
| Catalog Number | C6623 |
| Lot Number | 1115499 |
| 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 | 2013-04-15 |