—#142022

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.

FDA product code: HET — Laparoscope, Gynecologic (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K111788
Affected lot / code info: Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767, 622769, 622771, 622773, 622775, 622777, 622778, 622785, 622789, 622795, 622797, 622798, 622801, 622806, 623624, 623626, 623629, 623637, 623638, 623639, 623641, 623661, 623669, 623671, 623672, 623673, 623677, 623687, 623688, 623705, 623709, 623713, 623719, 623720, 623722, 623723, 623729, 623730, 623731, 623735, 623736, 623737, 623738, 623739, 623740, 623741, 623742, 623743, 623747, 623749, 623750, 623751, 623752, 623776, 623778, 623784, 623786, 623787, 623788, 623799, 623800, 623801, 623802, 624004, 624005, 624006, 624008, 624011, 624012, 624016, 624017, 624018, 624019, 624024, 624028, 624030, 624041, 624042, 624046, 624054, 624055, 624056, 624057, 624064, 624066, 624070, 624071, 624073, 624076, 624077, 624080, 624082, 624089, 624099, 624100, 624101, 624104, 624107, 624109, 624110, 624112, 624114, 624117, 624119, 624121, 624151, 624158, 624162, 624167, 624170, 624618, 624622, 624643, 624678, 624679, 624682, 624683, 624720, 622539, 622540, 622570, 622572, 623734, 623748, 624739, and 624741.

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-11-17
Posted by FDA: 2015-12-10
Terminated: 2017-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.