MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-09-10 for CUSA EXCEL 23KHZ STANDARDTIP C4601S manufactured by Integra Lifesciences (ireland) Limited.
[3746272]
The second report of two from the same facility involving a cusa 23khz tip. The event was described as follows: the staff changed the new c4601s tip (lot no. 1122361, exp 2015-05). They switched off the cusa excel main switch. They opened the cusa excel main switch. They pushed the "test" button. It was reported that tip #2 broke into two parts during setup for liver surgery, after 5 minutes. The unit was not in contact with a patient when it broke. The hand piece settings were 70, 70, 70 and a nosecone was being used. It was reported that the tip did not contact another instrument or tool. The patient did not incur an injury and the surgery was not delayed as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11112006]
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 | 3006697299-2013-00066 |
| MDR Report Key | 3368133 |
| Report Source | 01,08 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-09-10 |
| Date of Event | 2013-08-19 |
| Date Mfgr Received | 2013-08-20 |
| Date Added to Maude | 2013-12-09 |
| 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 DR. |
| Manufacturer Phone | 6099365560 |
| 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 | 2013-09-10 |
| Catalog Number | C4601S |
| Lot Number | 1122361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-09-10 |