Hugo RAS MRASI0001 (UDI 10884521826694)Recalls & reported problems
Covidien LP · Monopolar Curved Shears · Class 2
All models of Hugo RAS (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Covidien Hugo RAS monopolar curved shears, a hand-controlled surgical instrument used to cut and cauterize tissue during robotic surgery. The 46 reports mostly describe the instrument breaking, twisting, being hard to remove, or losing communication with the console, with display and feedback problems also common. One report describes tissue damage and a small intestinal tear; no deaths were reported and one injury was reported. There are no recalls naming this device. All 46 reports came in the past 12 months, with none in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10884521826694), received between Dec 12, 2025 and Sep 30, 2026 — classified as 3 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Break” (19 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, 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
- Break19
- Difficult to Remove18
- Display or Visual Feedback Problem16
- Communication or Transmission Problem12
- Intermittent Communication Failure11
- Failure to Cut7
- Component or Accessory Incompatibility4
- Difficult or Delayed Activation4
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Foreign Body In Patient2
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 54 reports, 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 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 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 ↗MalfunctionSep 1, 2026Break; Component or Accessory Incompatibility; Device Fell
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549265 ↗MalfunctionSep 1, 2026Break; Separation Failure; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547807 ↗MalfunctionAug 28, 2026Break; Display or Visual Feedback Problem; Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506312 ↗MalfunctionAug 25, 2026Difficult to Remove; Component or Accessory Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438849 ↗MalfunctionAug 20, 2026Component or Accessory Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358855 ↗MalfunctionAug 18, 2026Break; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309185 ↗MalfunctionAug 12, 2026Display or Visual Feedback Problem; Difficult to Remove; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228557 ↗MalfunctionAug 11, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215111 ↗MalfunctionAug 4, 2026Display or Visual Feedback Problem; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136460 ↗MalfunctionJul 29, 2026Display or Visual Feedback Problem; Difficult to Remove; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074580 ↗InjuryJul 28, 2026Break; Device Fell
It was reported that, during a robotic laparoscopic radical prostatectomy procedure, the tip of the Monopolar Curved Shears (MCS) br oke off and fell into the patient¿s cavity. The team searched for the broken part using a magnet. An X-ray was not used because the team believed there was a high probability that the part had been removed by the suction device. The instrument was replaced with a new one.
Patient problems: Foreign Body In Patient
MAUDE report 50062871 ↗MalfunctionJul 27, 2026Difficult to Remove; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003168 ↗MalfunctionJul 27, 2026Communication or Transmission Problem; Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000338 ↗MalfunctionJun 23, 2026Intermittent Communication Failure
IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION IMMEDIATELY PRIOR TO STARTING CONSOLE OPERATIONS, A MONOPOLAR CURVED SHEARS (MCS) WAS ATTACHED TO THE SYSTEM BUT WAS NOT RECOGNIZED. EVEN AFTER REINSERTING THE INSTRUMENT THREE TIMES AND CLEANING THE STERILE INTERFACE MODULE (SIM) CONNECTION POINTS, THE ISSUE PERSISTED. ADDITIONALLY, SINCE THE LARGE NEEDLE DRIVER WAS RECOGNIZED WHEN USING THE SAME SIM, THE PRODUCT ITSELF WAS DETERMINED TO BE THE CAUSE. THE ISSUE WAS RESOLVED BY USING ANOTHER MCS TO PERFORM THE SURGERY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599333 ↗MalfunctionApr 1, 2026Display or Visual Feedback Problem; Intermittent Communication Failure
IT WAS REPORTED THAT PRE-OPERATIVELY DURING DOCKING, THE MONOPOLAR CURVED SHEARS(MCS) FAILED TO ATTACH TO THE INSTRUMENT DRIVE UNIT(IDU), RESULTING IN AN ERROR MESSAGE STATING "INSTRUMENT ERROR" IMMEDIATELY AFTER INSERTION. THE MCS WAS INSERTED THREE TIMES, EACH TIME FOLLOWED BY THE SAME ERROR, AND THE SYSTEM DID NOT RECOGNIZE THE MCS. THE STERILE INTERFACE MODULE(SIM) WAS ALSO REATTACHED, BUT THE ERROR PERSISTED. A NEW INSTRUMENT WAS USED, WHICH OPERATED PROPERLY. IT TOOK 10 MINUTES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754563 ↗MalfunctionMar 24, 2026Display or Visual Feedback Problem; Difficult to Remove; Intermittent Communication Failure
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE; WHILE PERFORMING DISSECTION, A HIGH PRIORITY ALARM OCCURRED ON THE MONOPOLAR CURVED SHEARS (MCS) CONNECTED TO STERILE INTERFACE MODULE (SIM). THE MCS BECAME DISABLED AND RESULTED IN LOSS OF TELEOPERATION. THE MCS WAS REMOVED FROM SIM USING THE BROKEN INSTRUMENT PROCEDURE, THEN RE-ATTACHED AND REINSERTED INTO THE PATIENT TO CONTINUE THE PROCEDURE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674707 ↗
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- Hugo RAS MRASC0003Covidien LP · Modular electromechanical surgical system2 reports
- Hugo RAS MRASI0001Covidien LP · Modular electromechanical surgical system1 report
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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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