MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for COBLATOR II ED13546-02 manufactured by Arthrocare Corp..
[25804591]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[39571881]
The unit was returned for evaluation and the complaint was verified. The root cause was determined to be associated with an electrical component failure within the control board which could have caused non-functionality of the leds and no recognition of connected wands. Factors unrelated to the design or manufacture of the device that could have contributed to the complaint event include: there may have been a power surge or interruption that could have caused internal component failure of the control board; there may have been an issue with the turbinate wand that could have caused internal component failure of the control board. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2015-00504 |
| MDR Report Key | 5060801 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-09-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 W WILLIAM CANNON DR. |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBLATOR II |
| Generic Name | OPERATOR CONSOLE, DIATHERMY UNIT |
| Product Code | BWA |
| Date Received | 2015-09-08 |
| Catalog Number | ED13546-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |