Hugo RAS MRASI0010 (UDI 10884521826748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521826748), received between Jan 23, 2026 and Sep 23, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 31, 2026Difficult or Delayed Activation

  It was reported that during a robotic-assisted radical prostatectomy laparoscopic procedure, while using the fourth arm for traction of the Dorsal Venous Complex (DVC) and bladder neck, the Secure Cadiere Forceps (SCF) did not grip tissue properly and tore tissue during traction. Additional sutures and another instrument were used to complete the traction. The surgery time was extended by more than 30 minutes.

  Patient problems: Tissue Breakdown

  MAUDE report 50104802 ↗
• MalfunctionJul 27, 2026Break; Difficult to Remove; Use of Device Problem; Component or Accessory Incompatibility

  It was reported that during the removal of a lymph node for a robotic-assisted laparoscopic radical prostatectomy with lymphadenectomy procedure, the Secure Cadiere Forceps experienced a breakage at the end of the gray shaft near the metal section and wrist. This occurred due to the Bipolar Maryland Forceps being moved and colliding with the Secure Cadiere Forceps, that was in the reserve arm out of the vision field. There was no damage done to the Bipolar Maryland Forceps. The broken instrument procedure was performed, and the Secure Cadiere Forceps was removed. A new trocar and a new Secure Cadiere Forceps were then inserted. There was no injury to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045888 ↗
• MalfunctionApr 17, 2026Display or Visual Feedback Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, AT THE START OF THE PROCEDURE AFTER DROPPING THE BLADDER, THE SECURE CADIERE FORCEPS (SCF) WAS RETRACTING TISSUE BUT WAS NOT GRASPING IT. THE SURGEON USED THE OTHER HAND AND A MARYLAND INSTRUMENT TO REMOVE THE TISSUE FROM THE SCF, AND THE INSTRUMENT WAS REMOVED USING THE INSTRUMENT DRIVE UNIT (IDU) AS NORMAL. ADDITIONALLY, THE SCF HAD AN INSTRUMENT ERROR WITH A RED ALARM. THE SCF WAS THEN REPLACED WITH A NEW INSTRUMENT TO RESOLVE THE ISSUE AND THE PROCEDURE CONTINUED. THERE WAS A 10-MINUTE DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911128 ↗
• MalfunctionFeb 23, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY WHILE THE SURGEON TRIED TO PULL ON THE PROSTATE, THE PROSTATE SLIPPED OUT OF THE GRASP OF THE SECURE CADIERE FORCEPS AS IF THE GRIP STRENGTH WAS WEAK. THE SECURE CADIERE WAS REPLACED WITH A NEW ONE, AND THIS RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415553 ↗
• MalfunctionFeb 16, 2026Intermittent Communication Failure

  IT WAS REPORTED THAT AT THE START OF A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, WHILE CONNECTING THE SECURE CADIERE FORCEPS INS TRUMENT TO THE ARM, THE SYSTEM DID NOT RECOGNIZE THE INSTRUMENT AND THE STERILE INTERFACE MODULE (SIM). THE INSTRUMENT WAS REPLACED WITH ANOTHER SECURE CADIERE FORCEPS TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343508 ↗
• MalfunctionFeb 3, 2026Difficult or Delayed Activation; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE; AFTER ATTACHING THE SECURE CADIERE FORCEPS (SCF) AND INSERTING IT INTO THE PATIENT, THE INSTRUMENT DISAPPEARED FROM THE INSTRUMENT BAR, WAS NO LONGER RECOGNIZED BY THE SYSTEM, AND COULD NOT BE USED. THE SCF WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245696 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem; Communication or Transmission Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY WHILE THE SURGEON WAS HOLDING THE SEMINAL VESICLES, THE SECURE CADIERE FORCEPS THREW A LOW PRIORITY ERROR STATING "INSTRUMENT ERROR. DETACHED THE INSTRUMENT, CLEAN AND DRY THE CONTACT SURFACES OF THE ACCESSORY. IF THE ERROR PERSISTS, DISCARD THE INSTRUMENT." THE INSTRUMENT STOPPED OPERATING FROM THE SURGEON CONSOLE AND COULD NOT BE MOVED. THE INSTRUMENT DRIVE UNIT BUTTON WAS DOUBLE CLICKED TO OPEN THE JAWS OF THE SECURE CADIERE AND THE INSTRUMENT WAS REMOVED. THE JAWS WERE CHECKED AND CLEANED, REATTACHED, REINSERTED, AND THERE WERE NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235086 ↗
• MalfunctionJan 23, 2026Component or Accessory Incompatibility

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY WITH LYMPADECTOMY, THE SECURE CADIERE FORCEPS COLLIDED WITH THE BIPOLAR FENESTRATED GRASPER. THERE WERE NO FURTHER ISSUES WITH THE SECURE CADIERE FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162725 ↗