Recalls / —
—#153345
Product
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
- FDA product code
- HET — Laparoscope, Gynecologic (And Accessories)
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K111788
- Affected lot / code info
- All serial numbers
Why it was recalled
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Root cause (FDA determination)
Device Design
Action the firm took
A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
Recalling firm
- Firm
- Olympus Corporation of the Americas
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-10
- Posted by FDA
- 2017-02-21
- Terminated
- 2018-05-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #153345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.