MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-05-24 for CUSA EXCEL 23KHZ STANDARDTIP C4601S manufactured by Integra Burlington, Ma, Inc..
[3461456]
Initially a c4601s cusa excel 23khz standard tip was reported to be defective on (b)(6) 2013. On (b)(6) 2013, add'l info changed this complaint to a (mdr) medical device report. The description was as follows; while the pt was anesthetized for liver surgery and reportedly the tip was not in contact with the pt after 15 mins the tip broke in two parts. A cem nosecone was not being used during this procedure and the tip did not solely touch the tissue. The pt did not incur an injury as a result of this event and there was no surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[10790924]
To date, the device involved in the reported incident has not been rec'd for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2013-00039 |
| MDR Report Key | 3134349 |
| Report Source | 01,08 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-05-24 |
| Date of Event | 2013-04-10 |
| Date Mfgr Received | 2013-05-02 |
| Date Added to Maude | 2013-08-06 |
| 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 | 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 STANDARDTIP |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-05-24 |
| Catalog Number | C4601S |
| Lot Number | 1122361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-24 |