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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01141-1
Product Name/Description ENDOEYE Video Telescope

ENDOEYE 10mm 0 degrees
Part #: WA50040A
S/N: 622642, 622770, 622774, 622776, 623616, 623617, 623618, 623620, 624087, 624088

ENDOEYE 10mm 30 degrees
Part #: WA50042A
S/N: 622506, 622529, 622530, 622531, 622532, 622533, 622781, 623665, 623667, 623684, 624075, 624094, 624619, 624627

ENDOEYE devices repaired with affected spare part
Part #: WA50040A or WA500422
S/N: 616960, 616963, 617144, 617801, 619863

ARTG Number: 121101
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/11/2015
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. Although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the ENDOEYE distal end could result in patient or user injury.
Recall Action Recall for Product Correction
Recall Action Instructions Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.
Contact Information 1300 657 699 - Olympus Customer Service