Hugo RAS MRASI0001 (UDI 10884521739949)Recalls & reported problems
Covidien LP · Monopolar Curved Shears · Class 2
All models of Hugo RAS (10)
Data updated Oct 16, 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 10884521739949), received between Apr 28, 2026 and Apr 28, 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 16, 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.
MalfunctionApr 28, 2026Intermittent Communication Failure
IT WAS REPORTED THAT, INTRA-OPERATIVELY TO A ROBOTIC LAPAROSCOPIC GYNECOLOGICAL PROCEDURE AS PART OF A CLINICAL STUDY, THE MONOPOLAR CURVED SHEARS (MCS) WERE NOT RECOGNIZED AND COULD NOT BE TELE-OPERATED. DUE TO THE INSTRUMENT BEING OUT OF THE FIELD OF VIEW, IT COULD NOT BE FULLY VISUALIZED BY THE SURGEON IN HIS ATTEMPTS TO MOVE IT BACK INTO THE FIELD OF VIEW. THE SURGEON, CONCERNED ABOUT THE SHARP INSTRUMENT BEING UNSEEN IN THE CAVITY, INSTRUCTED THE BEDSIDE ASSISTANT TO REMOVE THE SHEARS. THE BEDSIDE ASSISTANT REMOVED AND REINTRODUCED THE MCS TO RESOLVE THE ISSUE. THE MCS WAS DIFFICULT TO LOAD DUE TO BEING CAUGHT IN THE DRAPES. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023894 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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