Recall
FDAHealthAugust 21, 2024

Intuitive Surgical, Inc. — da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

⚠️ Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 21, 2024

US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.

What's affected?

Product
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Lot code
UDI-DI: 00886874119747. Serial Numbers: 10476314, 10485693, 10496049, 10497992, 10503432, 10503433, 10507302, 10509551, 10511044, 10511047, 10516467, 10518960, 10518961, 10522438, 10522439, 10522441, 10523771, 10523773, 10523775, 10523776, 10523777, 10523778, 10523779, 10523780, 10523781, 10529917, 10529918, 10529919, 10529920, 10529922, 10534426, 10534428, 10534429, 10534430, 10534752, 10534753, 10534754, 10534755, 10534757, 10543027, 10543028, 10543048, 10543051, 10544670, 10544676, 10544677, 10544678, 10547713, 10547717, 10547724, 10547728, 10551553, 10551554, 10552616, 10552618, 10552620, 10552621, 10556681, 10556682, 10558195, 10558197, 10558198, 10558202, 10560603, 10560604, 10560607, 10562584, 10562585, 10562586, 10562588, 10565609, 10565610, 10565614, 10567141, 10567143, 10567145, 10569365, 10569367, 10569368, 10569369, 10570704, 10570705, 10570706, 10570707, 10573677, 10573678, 10573679, 10573680, 10573681, 10573682, 10573683, 10573684, 10573685, 10573686, 10576019, 10576021, 10576022, 10576023, 10576024, 10576025, 10576026, 10576027, 10576028, 10579442, 10579446, 10579453, 10579455, 10579456, 10579457, 10579461, 10579466, 10582427, 10582428, 10582429, 10591177, 10591179, 10591180, 10591184, 10591197, 10594614, 10594615, 10594616, 10594617, 10594618, 10594619, 10597107, 10597108, 10597109, 10597110, 10599042, 10599044, 10599045, 10599048, 10600750, 10600753, 10603334, 10603335, 10603343, 10603344, 10603345, 10603367, 10605468, 10606129, 10606133

Additional details

UDI-DI: 00886874119747. Serial Numbers: 10476314, 10485693, 10496049, 10497992, 10503432, 10503433, 10507302, 10509551, 10511044, 10511047, 10516467, 10518960, 10518961, 10522438, 10522439, 10522441, 10523771, 10523773, 10523775, 10523776, 10523777, 10523778, 10523779, 10523780, 10523781, 10529917, 10529918, 10529919, 10529920, 10529922, 10534426, 10534428, 10534429, 10534430, 10534752, 10534753, 10534754, 10534755, 10534757, 10543027, 10543028, 10543048, 10543051, 10544670, 10544676, 10544677, 10544678, 10547713, 10547717, 10547724, 10547728, 10551553, 10551554, 10552616, 10552618, 10552620, 10552621, 10556681, 10556682, 10558195, 10558197, 10558198, 10558202, 10560603, 10560604, 10560607, 10562584, 10562585, 10562586, 10562588, 10565609, 10565610, 10565614, 10567141, 10567143, 10567145, 10569365, 10569367, 10569368, 10569369, 10570704, 10570705, 10570706, 10570707, 10573677, 10573678, 10573679, 10573680, 10573681, 10573682, 10573683, 10573684, 10573685, 10573686, 10576019, 10576021, 10576022, 10576023, 10576024, 10576025, 10576026, 10576027, 10576028, 10579442, 10579446, 10579453, 10579455, 10579456, 10579457, 10579461, 10579466, 10582427, 10582428, 10582429, 10591177, 10591179, 10591180, 10591184, 10591197, 10594614, 10594615, 10594616, 10594617, 10594618, 10594619, 10597107, 10597108, 10597109, 10597110, 10599042, 10599044, 10599045, 10599048, 10600750, 10600753, 10603334, 10603335, 10603343, 10603344, 10603345, 10603367, 10605468, 10606129, 10606133

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 144.

View original FDA notice →

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