GS 777 WALL TRANSFORMER W/OPHTH & OTO UK

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED BY THE CUSTOMER SO INSPECTION COULD NOT BE PERFORMED TO DETERMINE A ROOT CAUSE OF THE REPORTED EVENT. PER THE TECHNICIAN, THERE WAS NO EVIDENCE TO SHOW WHAT CAUSED THE SPARKING. THE GREEN SERIES (GS) 777 WALL SYSTEM CONSISTS OF A WALL TRANSFORMER AND ACCESSORIES THAT CAN BE USED WITH IT. GS 777 WALL SYSTEM THE GREEN SERIES (GS) 777 WALL TRANSFORMER SUPPLIES POWER TO TWO CORDED, HANDLE-BASED RHEOSTATS. THE CUSTOMER CAN ATTACH VARIOUS OTOSCOPE AND OPHTHALMOSCOPE HEADS TO THE HANDLES. THE INTENSITY OF THE LIGHT PRODUCED BY THE HEADS IS CONTROLLED BY TWISTING THE RHEOSTAT. THE PRODUCT IS CONNECTED TO A 5-WATT POWER SUPPLY VIA A USB 2.0 MINI-B TO TWIN USB CABLE. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED AND THE ROOT CAUSE COULD NOT BE CONFIRMED, IF THE AC PLUG WERE TO SPARK DURING USE, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE WALL SYSTEM'S TRANSFORMER PLUG HAS EVIDENCE OF SPARKING. BLACK SOOT ALL THROUGHOUT THE CONNECTOR BETWEEN THE PLUG BODY AND THE INBUILT UK PLUG SOCKET ADAPTER. THERE WAS NO ADVERSE EVENT REPORTED.