N
Patient 1
(B)(6).
MAUDE MDR 5060801
- MDR report key
- 5060801
- Report number
- 3006524618-2015-00504
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-03
- Date received
- 2015-09-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JIM GONZALES
- Address
- 7000 W WILLIAM CANNON DR. AUSTIN TX 78735 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COBLATOR II | OPERATOR CONSOLE, DIATHERMY UNIT | ARTHROCARE CORP. | BWA | ED13546-02 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-08 | 0 |
Event Narratives#
N
Patient 1
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.