Recall Z-0403-2016— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2015-11-17, terminated 2017-01-24. It names one FDA 510(k) clearance: K111788. Product: Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.. Reason: A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-17
- Terminated
- 2017-01-24
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Reason for recall
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.