Returned for evaluation were two starburst xl probes of lot number 5434948.Visual/microscopic exam: a visual review of the device noted no obvious visual defects.Functional check: sample #1 the device was connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.Sample #2 the device was connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.The customer's reported complaint description was not confirmed.The root cause could not be determined; the defect was not repeated, and no issues found during testing.Both the devices were connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.Opened up the device and checked all connections and wires.Could not duplicate the reported failure.Labeling review: the instructions for use, which is supplied to the user with this catalog number, contains the following statements: "verify that each of the device temperature needles is functioning by holding the temperature needles between your sterile, gloved fingers.The temperature readings on the rf generator should increase within 30 seconds.If they do not, check connections and try again." a review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference # (b)(4).
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