Navio PFSR110001Recalls & reported problems
Smith & Nephew, Inc. · Navio Camera Cart · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556628461), received between Feb 15, 2022 and Sep 24, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Intermittent Communication Failure” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Intermittent Communication Failure1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2022Intermittent Communication Failure; Intermittent Communication Failure
IT WAS REPORTED THAT, DURING SET UP FOR NAVIO ASSISTED PFA PROCEDURE, THE NAVIO CAMERA CART WAS NOT ABLE TO BE DETECTED. TWO SYSTEM REPORTS WERE ALSO TRIED BUT WITH NO SUCCESS. NO PROMPTS WERE INDICATED BUT THE COLLAR PORTION OF THE CABLE WAS NOT ENGAGING WELL WITH THE NAVIO UNIT. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15480844 ↗InjuryFeb 15, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED SURGERY, THE NAVIO CAMERA CART DID NOT SHOW A NOTIFICATION FOR "CONNECTED" WHEN THE HARDWARE COMPONENT WAS CONNECTED. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT DELAYS. THE PATIENT WAS NOT HARMED. ADDITIONALLY, AFTER INSPECTION OF THE DEVICE, IT WAS FOUND THAT THERE WAS A LOOSE CONNECTION. THEY RE-CONNECTED THE DEVICE AND IT BOOTED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13536963 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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