MalfunctionFET

TELE PACK X LED MONITOR 15" LCD Z

Received May 13, 2026

Report MW5188196 · MDR key 25167373

Device

Generic name

Endoscopic Video Imaging System/component, Gastroenterology-urology

Manufacturer

Karl Storz Endoscopy-america, Inc.

Patient

NA · Unknown

Insufficient Information

Narrative

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 6/1/2026 FOR REPORT NUMBER MW5188196 TO CORRECT THE PROCODE TO FET.

Description of Event or Problem

IT WAS REPORTED THAT MOISTURE WAS DETECTED INSIDE THE VIDEO ENDOSCOPE. AS A RESULT, THE IMAGE APPEARED BLURRY, AND ONLY CHANGES IN LIGHTING WERE OBSERVABLE. THE COMPONENT WAS RECOGNIZED BY THE SYSTEM; HOWEVER, NO IMAGE WAS DISPLAYED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).