Hugo RASRecalls & reported problems across all models
Covidien LP · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 10 models of Hugo RAS by Covidien LP in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2025 and Sep 30, 2026 — classified as 3 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (23 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hugo RAS problems
Device problems
- Display or Visual Feedback Problem23
- Break20
- Difficult to Remove19
- Intermittent Communication Failure19
- Communication or Transmission Problem16
- Difficult or Delayed Activation8
- Failure to Cut7
- Component or Accessory Incompatibility6
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Foreign Body In Patient2
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- Tissue Breakdown1
- Unintended Radiation Exposure1
Hugo RAS models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hugo RAS MRASI0001Modular electromechanical surgical system54 reports
- Hugo RAS MRASI0010Modular electromechanical surgical system9 reports
- Hugo RAS MRASC0001Modular electromechanical surgical system4 reports
- Hugo RAS MRASC0002Modular electromechanical surgical system3 reports
- Hugo RAS MRASC0003Modular electromechanical surgical system2 reports
- Hugo RAS MRASI0001Modular electromechanical surgical system1 report
- Hugo RAS MRASI0001Modular electromechanical surgical system1 report
- Hugo RAS MRASI0004Modular electromechanical surgical system1 report
- Hugo RAS MRASI0006Modular electromechanical surgical system1 report
- Hugo RAS MRASI0010Modular electromechanical surgical system1 report
Recent Hugo RAS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950520 ↗MalfunctionSep 28, 2026Display or Visual Feedback Problem; Difficult to Remove; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924243 ↗InjurySep 28, 2026Communication or Transmission Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50923161 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904126 ↗MalfunctionSep 23, 2026Difficult to Insert; Communication or Transmission Problem
It was reported that, prior to a robotic laparoscopic partial nephrectomy procedure, while the patient was in the operating room, during docking and instrument insertion, the Secure Cadiere Forceps would not insert into the trocar and did not move. The team attempted to reconnect the instrument, but ultimately decided to use a new Secure Cadiere Forceps, which worked properly. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866046 ↗MalfunctionSep 17, 2026Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809036 ↗MalfunctionSep 17, 2026Failure to Calibrate; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808981 ↗MalfunctionSep 17, 2026Application Program Freezes or Fails to Launch; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808949 ↗MalfunctionSep 11, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739984 ↗InjurySep 11, 2026Break; Component or Accessory Incompatibility; Device Fell
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 50739568 ↗MalfunctionSep 8, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677596 ↗MalfunctionSep 8, 2026Failure to Calibrate; Application Program Freezes or Fails to Launch
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676279 ↗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 ↗MalfunctionSep 2, 2026Break; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570063 ↗MalfunctionSep 2, 2026Break; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569715 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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