OR1 NEO IP, ENH2 3.1.0.10
Received May 28, 2026
Report 9610617-2026-01216 · MDR key 25318951
Device
Generic name
Or1 Neo Ip, Enh2 3.1.0.10
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2548-02Catalog 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.