HUGO¿ RAS SYSTEM
Report
- Report Number
- 1219930-2026-00118
- Event Type
- Malfunction
- Date Received
- January 7, 2026
- Date of Event
- December 22, 2025
- Report Date
- March 24, 2026
- Manufacturer
- SURGICAL
- Product Code
- SCV
- UDI-DI
- 10884521836242
- PMA / PMN Number
- K250725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE FIELD SERVICE NOTES AND ASSOCIATED DEVICE DATA FOR THE REPORTED ARM CART ASSEMBLY (ACA). REVIEW OF THE FIELD SERVICE NOTES INDICATES THAT THE ISSUE WAS REPRODUCED AND CONFIRMED IN THE FIELD. THE ISSUE WAS RESOLVED BY RES EATING THE INSTRUMENT DRIVE UNIT (IDU), SUGGESTING A TEMPORARY CONNECTION OR INITIALIZATION FAULT. AFTER RESEATING THE IDU, THE ARM WAS IN WORKING CONDITION. EVALUATION OF THE DEVICE DATA INDICATES OCCURRENCE OF AN ERROR CODE ¿ROBOTIC ARM JOINT FORCE MEASUREMENTS MARKED INVALID¿. LOGS INDICATE THAT THE ARM EXPERIENCED A NON-RECOVERABLE ERROR DUE TO THE JOINT FORCE SENSOR (JFS) READINGS BEING MARKED AS INVALID. EVALUATION OF THE ARM CART ASSEMBLY CONFIRMED THE REPORTED CONDITION. THE ROOT CAUSE OF THE OBSERVED ERRORS WAS DETERMINED TO BE RELATED TO CONNECTIVITY ISSUES BETWEEN THE Z-SLIDE AND INSTRUMENT DRIVE UNIT (IDU). THIS IS TRACED TO DEVICE DESIGN SUCH AS SMALL MOVEMENTS IN THE CONNECTOR DUE TO IMPACT OR AN INADEQUATE STRAIN RELIEF THAT CAUSE THE CONTACTS TO SHIFT ONTO REGIONS OF THE MATING CONTACTS THAT ARE CONTAMINATED WITH FLUX, WHICH PREVENTS ELECTRICAL CONDUCTIVITY. ADDITIONALLY, DAMAGE TO THE ASSEMBLY FIXTURE PIN ALLOWED TOO MUCH INTERFERENCE BETWEEN CONNECTOR COMPONENTS, LEADING TO CONNECTOR DAMAGE AND LOSS OF CONNECTIVITY. IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS CONDITION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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.
IT WAS REPORTED THAT PRIOR TO A CHOLECYSTECTOMY PROCEDURE, WITH NO PATIENT IN THE OPERATING ROOM, DURING THE DRAPING PROCESS THE ARM CART ASSEMBLY WAS FROZEN. THERE WAS AN ERROR STATING, "ARM ERROR. IF INSTRUMENT INSERTED, USE MECHANICAL RELEASES TO WITHDRAW. IF NO INSTRUMENT, UNPLUG AND REPLUG ARM.". THE LIGHT EMITTING DIODES (LEDS) ON THE ARM WERE STILL WORKING. TO RESOLVE THE ISSUE, TRIED TO RECONNECT THE ARM, BUT COULD NOT CALIBRATE IT. FINALLY USED ANOTHER ARM. TOOK AROUND FIFTEEN MINUTES TO RESOLVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
IT WAS REPORTED THAT PRIOR TO A CHOLECYSTECTOMY PROCEDURE, WITH NO PATIENT IN THE OPERATING ROOM, DURING THE DRAPING PROCESS THE ARM CART ASSEMBLY WAS FROZEN. THERE WAS AN ERROR STATING, "ARM ERROR. IF INSTRUMENT INSERTED, USE MECHANICAL RELEASES TO WITHDRAW. IF NO INSTRUMENT, UNPLUG AND REPLUG ARM.". THE LIGHT EMITTING DIODES (LEDS) ON THE ARM WERE STILL WORKING. TO RESOLVE THE ISSUE, TRIED TO RECONNECT THE ARM, BUT COULD NOT CALIBRATE IT. FINALLY USED ANOTHER ARM. TOOK AROUND FIFTEEN MINUTES TO RESOLVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68964 | HUGO¿ RAS SYSTEM | MODULAR ELECTROMECHANICAL SURGICAL SYSTEM | SCV | SURGICAL | MRASC0002 | 10884521836242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |