MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-11-08 for CUSA EXCEL 23KHZ TUBING SET C3600 manufactured by Integra Neurosciences Pr.
[19022566]
During surgery but before the cusa was used and while mounting the hand piece, it was discovered that the clamp that locks the aspiration tube (cusa excel 23khz tubing) into the handpiece was mounted upside down. As a result of this issue the surgery was delayed 30 minutes. The pt was anesthetized when the problem was found but the pt did not incur an injury as a result of the delay or the issue.
Patient Sequence No: 1, Text Type: D, B5
[19277338]
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 | 3006697299-2013-00075 |
| MDR Report Key | 3566053 |
| Report Source | 01,08 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-11-06 |
| Date Added to Maude | 2014-02-14 |
| 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 TUBING SET |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-11-08 |
| Catalog Number | C3600 |
| Lot Number | 0000001132074 |
| 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 | 2013-11-08 |