DYONICS RF-S WHIRLWIND ABLATION 90° PROBE WITH INTEGRATED CABLE
Received Oct 16, 2015 · Event occurred Jul 23, 2015
Report 3006524618-2015-00537 · MDR key 5157403
Device
Generic name
Electrode, Electrosurgical, Active, Foot-controlled, Single Use
Manufacturer
Arthrocare Corp.Catalog number
72202139
Lot number
1002696
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICES IN QUESTION WERE NOT RETURNED FOR EVALUATION. THUS, THE CUSTOMER¿S COMPLAINT COULD NOT BE VERIFIED, NOR COULD A ROOT CAUSE BE DETERMINED WITH CONFIDENCE. IT IS POSSIBLE THAT PRE-WARMED SALINE WAS USED, INSUFFICIENT SUCTION WAS CONNECTED OR THE PATIENT WAS NOT SUFFICIENTLY DRAPED. THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE, CONTAIN MANY WARNINGS AND PRECAUTIONARY STATEMENTS RELATED TO PROPER CONNECTION OF THE SYSTEM, INCLUDING BUT NOT LIMITED TO THE FOLLOWING. "FOR DYONICS RF PROBES WITH SUCTION LUMENS, USE OF THE LUMEN AS THE SOLE OUTFLOW PATHWAY FOR IRRIGATION IS NOT RECOMMENDED. THIS MAY RESULT IN THERMAL INJURY TO THE PHYSICIAN AND PATIENT. DYONICS RF PROBES WITH SUCTION SHOULD BE USED IN CONJUNCTION WITH A SECONDARY SOURCE OF OUTFLOW." "WHEN USING DYONICS RF PROBES, ENSURE ADEQUATE FLOW AND CIRCULATION OF SALINE SOLUTION TO PREVENT UNNECESSARY HEATING OF THE SOLUTION THAT MAY RESULT IN TISSUE DAMAGE." "FOR DYONICS RF PROBES WITH SUCTION, FAILURE TO ATTACH THE SUCTION ADAPTER MAY CAUSE THERMAL INJURY TO THE PHYSICIAN OR PATIENT" - "DO NOT USE PRE-WARMED SALINE WITH THE DYONICS RF PROBES, WHICH MAY RESULT IN TISSUE DAMAGE OR THERMAL INJURY." "WARNING: FOR DYONICS RF PROBES WITH SUCTION, FAILURE TO ATTACH THE SUCTION ADAPTER MAY CAUSE THERMAL INJURY TO THE PHYSICIAN OR PATIENT." THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.
Description of Event or Problem
IT WAS REPORTED THAT DURING A POST-OPERATIVE APPOINTMENT, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A BURN TO THE INSIDE OF THE RIGHT ARM FOLLOWING A PROCEDURE USING A DYONICS RF WHIRLWIND 90 DEGREE PROBE WITH A DYONICS RF GENERATOR. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE SEVERITY OF THE BURN OR ANY TREATMENT ADMINISTERED, HOWEVER THERE HAVE BEEN NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.