Hugo RAS MRASI0004Recalls & reported problems
Covidien LP · Bipolar Fenestrated Grasper · Class 2
All models of Hugo RAS (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521850958), received between Sep 8, 2026 and Sep 8, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Intermittent Communication Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Intermittent Communication Failure
It was reported that during a robotic-assisted liver resection laparoscopic procedure, during initial instrument attachment after do cking, the Bipolar Fenestrated Grasper (BFG) displayed a message indicating that it could not be recognized by the arm or Sterile Interface Module (SIM), and insertion was disabled. Undocking, unbraking the cart, redocking, and retrying insertion did not resolve the issue. A different instrument was then attached to confirm functionality of the arm and SIM, and that instrument inserted successfully. The BFG was replaced with another instrument, and the case proceeded. There was no injury to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671281 ↗
Other Modular electromechanical surgical system devices
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- Versius Surgeon Console V-SS-1020Cmr Surgical Limited · Modular Electromechanical Surgical System1 recall0 reports
- Hugo RAS MRASI0010Covidien LP · Modular electromechanical surgical system9 reports
- Hugo RAS MRASC0001Covidien LP · Modular electromechanical surgical system4 reports
- Versius Camera Head (compatible with vLimeLite) 90911Cmr Surgical Limited · Modular Electromechanical Surgical System3 reports
- Hugo RAS MRASC0002Covidien LP · Modular electromechanical surgical system3 reports
- Hugo RAS MRASC0003Covidien LP · Modular electromechanical surgical system2 reports
- Hugo RAS MRASI0001Covidien LP · Modular electromechanical surgical system1 report
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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