Hugo RAS MRASI0006Recalls & reported problems
Covidien LP · Large Needle Driver · 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 10884521850972), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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
- Display or Visual Feedback Problem1
- 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.
MalfunctionMar 25, 2026Display or Visual Feedback Problem; Intermittent Communication Failure
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, THE MONOPOLAR CURVED SHEARS (MCS) WERE NOT PERFORMING LIKE IT SHOULD DURING BLADDER TAKEDOWN, SPECIFICALLY WITH COLD CUTTING. THE PHYSICIAN WAS NOT SATISFIED WITH THE PERFORMANCE OF THE MCS. THE MCS WERE SWAPPED WITH ANOTHER MCS WHICH WAS SATISFACTORY TO THE PHYSICIAN AND THE SURGERY CONTINUED WITH VERY LITTLE DELAY. ADDITIONALLY, THE LARGE NEEDLE DRIVER HAD AN OUT OF THE BOX FAILURE. THE LND WAS NOT RECOGNIZED WITHIN THE SIXTY SECOND WINDOW WHICH CAUSED A YELLOW INSTRUMENT ERROR. INSTRUCTED BEDSIDE ASSIST TO DETACH THE INSTRUMENT, RECONNECTED INSTRUMENT BUT SAME ERROR. AFTER SIXTY SECONDS OF USE, IT ALARMED ONCE MORE. THE LND WAS SWITCHED FOR A NEW LND AND IT WAS RECOGNIZED AND THE SURGERY CONTINUED SUCCESSFULLY. THERE WAS NO ISSUE WITH THE STERILE INTERFACE MODULE (SIM). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688966 ↗
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- 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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