inforMED
MalfunctionLMD

OR1 NEO IP, ENH2 2.5

Received Jul 17, 2026

Report 9610617-2026-01656 · MDR key 25860691

Device

Generic name

Or1 Neo Ip, Enh2 2.5

Model number

WUIS2548-01

Catalog number

WUIS2548-01

Product problems

  • Fire

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, A SMALL FIRE THAT OCCURRED AT PIH HEALTH WHITTIER, OR 11 LAST NIGHT THAT WAS TRACED BACK TO THE CABINET HOUSING ALL THE KARL STORZ INTEGRATION EQUIPMENT. AT THIS TIME, THE FACILITY HAS SUSPENDED ALL CASES IN EVERY OR SUITE UNTIL KARL STORZ CAN ASSESS EACH ROOM AND PROVIDE CLEARANCE.

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.