HUGO¿ RAS SYSTEM
Received Jul 7, 2026 · Event occurred Jun 18, 2026
Report 1219930-2026-04299 · MDR key 25732780
Device
Product problems
- Unintended Collision
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC TRANS ABDOMINAL PRE PERITONEAL (TAPP) PROCEDURE, THE LEFT ARM CART ASSEMBLY (ACA) REPEATEDLY COLLIDED WITH THE PATIENT'S HEAD. THE TEAM ATTEMPTED TO ADJUST THE TILT ANGLE, TENT THE TROCAR TO SEPARATE THE ROBOTIC ARM FROM THE PATIENT¿S HEAD, AND MODIFY THE TRENDELENBURG ANGLE OF THE SURGICAL BED. HOWEVER, THE ISSUE PERSISTED AND THE SURGERY WAS CONVERTED TO LAPAROSCOPY.