MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-01-21 for CUSA EXCEL 23KHZ STANDARDTIP C4601S manufactured by Integra Lifesciences Ireland Limited.
[17569243]
This is the second of three reports regarding c4601s - cusa excel 23khz. Standardtip (same reporter, same product id, same lot number, different pts). A new c4601s tip was used with a c2600 cusa handpiece during liver surgery. The user turned off the cusa excel main switch and then turned it on. The "test" button was pushed. Then, it was reported that the tip was broken in two parts after 10 minutes. The panel showed the tip alarm. Add'l info was requested from the distributor and on (b)(6) 2014, the following was provided: a (b)(6) year old male patient underwent liver surgery. The tip was not being used on the patient at the time it broke. The distributor did not know the circumstances of how the tip broke. The tip was not being used near or next to another metal instrument. There was no pt harm or injury. There was no surgical delay. A replacement tip was available to be used. It was reported that the tip has previously been used one time before.
Patient Sequence No: 1, Text Type: D, B5
[17714324]
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 | 3006697299-2014-00004 |
| MDR Report Key | 3726591 |
| Report Source | 01,08 |
| Date Received | 2014-01-21 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-23 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-05-06 |
| 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 |
| 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 | CUSA EXCEL 23KHZ STANDARDTIP |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-01-21 |
| Catalog Number | C4601S |
| Lot Number | 1125734 |
| Device Expiration Date | 2015-12-31 |
| 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 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-21 |