Life extension without disclosed testing: a model-level verification audit of FDA-cleared remanufactured da Vinci instruments, 2022– 2026

Abstract Purpose The US Food and Drug Administration (FDA) has cleared remanufactured da Vinci instruments for additional clinical uses since 2022. We assessed whether surgical teams can verify, from public records, each model’s intended lifetime, the testing behind its added uses, and its identity in adverse-event reports. Methods Cross-sectional audit of all eight 510(k) clearances under product code QSM (nine models) through 22 October 2026. Each 510(k) summary was coded across ten validation domains (90 cells) and linked to dated original equipment manufacturer (OEM) policy-page versions, securities filings, court records, and FDA adverse-event reports. Two coding passes were compared and adjudicated against source documents. Results Every numeric life-extension claim (ten added uses; four models) applied to a monopolar energy instrument, yet no summary reported a test sample size, cycle exposure, acceptance criterion, or electrical-safety result, and none unambiguously stated the original labeled use count. Six of eight clearances cited another clearance for their test methods, leaving three evidence lineages. The OEM first listed cleared models in a page version dated March 2025, 897 days after the first clearance. All 26 identified adverse-event reports concerned scissors; 23 were filed by the OEM about a competitor’s product, 23 carried the OEM product code, and one carried a cohort model number. Conclusion Public records confirm which remanufactured instruments are cleared but not how far their life has been tested or which device a failure report concerns. A ten-item model-level verification record would support procurement, point-of-use review, and surveillance.