inforMED
MalfunctionSCV

HUGO¿ RAS SYSTEM

Received Jul 6, 2026 · Event occurred Jul 2, 2026

Report 1219930-2026-04271 · MDR key 25718790

Device

Generic name

Modular Electromechanical Surgical System

Manufacturer

Surgical

Model number

MRASC0005

Catalog number

MRASC0005

Product problems

  • Use of Device Problem
  • Complete Loss of Power

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT, PREOPERATIVELY, DURING SETUP FOR AN INGUINAL HERNIA PROCEDURE, A CABLE BECAME DISCONNECTED WHEN THE SURGEON CONSOLE HAD TO BE MOVED FOR APPLICABLE SETUP, AS IT WAS STUCK TO AN OVERLY TIGHT TOWER POWER SUPPLY CABLE (TPSC), INADVERTENTLY PULLING IT LOOSE. AS A RESULT, THE SYSTEM BATTERY DISCHARGED DOWN TO ~78% WHILE THE CARTS REMAINED ATTACHED. THE CABLE WAS RECONNECTED, AND THE TOWER WAS SHUT DOWN TO PREVENT FURTHER DRAIN OF THE UNINTERRUPTED POWER SUPPLY (UPS). THE PROCEDURE WAS CONVERTED DUE TO THE REQUIRED RECHARGE TIME OF APPROXIMATELY 22 TO 44 MINUTES. NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.