Recall Z-0403-2016 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 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.
| Date | Dec 10, 2015 (initiated Nov 17, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Olympus Corporation of Americas sent a letter dated November 25, 2015, to all affected customers to inspect the serial #'s to identify if the affected lots were in inventory and discontinue of the affected lots. Then return all aftected lots for repair and service. Customers were instructed to contact the Customer Care Center at 800-537-5739, Option 2 for instructions on returninng the ENDOEYE for repair and service. The form should be faxed to 484-896-7128. Customers with questions were instructed to call 484-896-5688. |
| Quantity | 182 |
| Distribution | US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111788 | ENDOEYE HD II Olympus America, Inc., Jan 13, 2012 |