MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-02-07 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Lifesciences Ireland Limited.
[4433406]
Surgeon could not use handpiece because of a the tip alarm that occurred during the tip testing. The handpiece was not in contact with pt. The surgeon had to wait for loaner handpiece. There was no pt injury or death alleged. The event lead to a 2 hour 30 minute increase in surgery time. Additional info was requested and on (b)(6) 2014, the following was provided: it was confirmed that the pt was not injured and the tip alarm occurred when testing the tip. When the problem occured, the pt was already anesthetized. The pt had a craniotomy. The surgeon had to wait 2 hours 30 minutes for the loan handpiece. No other info was provided.
Patient Sequence No: 1, Text Type: D, B5
[11876056]
To date, the device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2014-00011 |
| MDR Report Key | 3784912 |
| Report Source | 01 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-15 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-02-07 |
| Date Added to Maude | 2014-05-19 |
| 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 | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBOROR NJ 085360000 |
| Manufacturer Country | US |
| Manufacturer Postal | 085360000 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2014-02-07 |
| Returned To Mfg | 2014-01-21 |
| Catalog Number | C2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Address | SRAGH, TULLAMORE, CO. OFFALY 0000 IT 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |