MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-09-17 for CUSA EXCEL 36KHZ EXTENDED MICRO XXX-CUSATIP manufactured by Integra Neurosciences Pr.
[3771389]
The surgeon reported that he stated using the cusa on the liver. Five (5) minutes into the case the tip end broke and sheared off. The scrub nurse recovered the tip and replaced it with a new tip from the same box. The surgeon began again but the same failure occurred. The event lead to a significant increase of surgery time: 60 minutes. The pt did not incur an injury as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[11263607]
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 | 3006697299-2013-00069 |
| MDR Report Key | 3392966 |
| Report Source | 01,05 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-09-17 |
| Date of Event | 2013-08-28 |
| Date Mfgr Received | 2013-08-29 |
| Date Added to Maude | 2013-12-23 |
| 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 36KHZ EXTENDED MICRO |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-09-17 |
| Catalog Number | XXX-CUSATIP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-17 |