inforMED
MalfunctionLMD

OR1 NEO IP, ENH2 3.X

Received Dec 19, 2025

Report 9610617-2025-02381 · MDR key 23853576

Device

Generic name

Or1 Neo Ip, Enh2 3.x

Model number

WUIS2548-02

Catalog number

WUIS2548-02

Product problems

  • Optical Problem
  • Optical Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE FOLLOWING WAS REPORTED: "DURING PROCEDURE TODAY... IN OR 12, THE NEO IP PREVIEW IMAGE FROZE AND WE WERE UNABLE TO SELECT ANY SOURCES. THE PREVIEW IMAGE FOR AIDA CH 2 FROZE ON THE PREVIEW IMAGE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, A SERVICE TECH WILL BE SENT TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4). THIS PRODUCT IS MANUFACTURED AT (B)(6).