Recall Z-1929-2017 ยท HET Laparoscope, Gynecologic (And Accessories)
Olympus Corporation of the Americas
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
| Date | Feb 21, 2017 (initiated Feb 10, 2017) |
| Status | Terminated |
| Reason | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| Root cause | Device Design |
| Action | A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor. |
| Quantity | 863 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111788 | ENDOEYE HD II Olympus America, Inc., Jan 13, 2012 |