inforMED
MalfunctionLMD

OR1 NEO IP, ENH2 3.1.0.10

Received May 19, 2026

Report 9610617-2026-01130 · MDR key 25219183

Device

Generic name

Or1 Neo Ip, Enh2 3.1.0.10

Model number

WUIS2548-02

Catalog number

WUIS2548-02

Product problems

  • Unexpected Shutdown

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, UPS POWERS DOWN BY ITSELF AND SUBSEQUENTLY POWERS DOWN ALL INTEGRATION. THE ONLY WAY TO RESOLVE THE ISSUE IS BY MANUALLY POWERING BACK ON THE UPS AND NEO-IP COMPONENTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION 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 KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY.