inforMED
MalfunctionFEM

SCOPEYE

Received May 13, 2026

Report MW5188235 · MDR key 25173463

Device

Generic name

Accessories, Photographic, For Endoscope (exclude Light Sources)

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

(B)(6) (CC) CALLED TO REPORT THAT DURING SURGERY, THE SCOPEYE WENT UNRESPONSIVE. THE SURGEON STATED THAT THE HEADSET STAYED UNRESPONSIVE FOR AROUND 30 SECONDS, WHILE THE STEALTH SCREEN WAS NAVIGATING AS EXPECTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).