MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-07 for CUSA EXCEL 23KHZ TUBING SET C3600 manufactured by Integra Neurosciences Pr.
[3003174]
C3600 a cusa excel 23khz tubing set; tubing was found to be torn. The problem was found during the surgery when a puddle was found on the floor. The tubing was inserted properly at 10 am and it wasn't until 4pm that same day that a puddle was noted under the cusa. Upon further inspection it was found that possibly contaminated fluid was still getting into the tubing. The craniotomy was delayed approximately 15 minutes. It is unknown at this time whether the patient experienced an injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10318748]
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 | 2648988-2012-00048 |
| MDR Report Key | 2837442 |
| Report Source | 05 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-11-07 |
| Date of Event | 2012-10-24 |
| Date Mfgr Received | 2012-10-24 |
| Date Added to Maude | 2013-02-13 |
| 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 TUBING SET |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2012-11-07 |
| Catalog Number | C3600 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-11-07 |