inforMED
MalfunctionGCM

VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°

Received Jun 29, 2026

Report 9610773-2026-04655 · MDR key 25652446

Device

Generic name

Rigid Video Laparoscope

Model number

WA50080A

Product problems

  • Poor Quality Image
  • Communication or Transmission Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CONNECTION ERROR AND SHOWED LINES INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.