OR1 NEO IP, ENH2 2.5
Received Jul 7, 2026
Report 9610617-2026-01551 · MDR key 25736530
Device
Generic name
Or1 Neo Ip, Enh2 2.5
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2548-01Catalog number
WUIS2548-01
Product problems
- Complete Loss of Power
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE INFORMATION RECEIVED, PS32+ POWER SOURCE DIED. 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.