inforMED
InjuryLMD

OR1 NEO IP, ENH

Received Sep 13, 2023 · Event occurred Jun 17, 2020

Report 2020550-2023-00257 · MDR key 17741196

Device

Generic name

Or1 Neo Ip, Enh

Model number

WUIS2546

Catalog number

WUIS2546

Product problems

  • Complete Loss of Power
  • Complete Loss of Power

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE STOPPED WORKING DURING THE PROCEDURE. NO HARM OCCURRED TO THE PATIENT, BUT THE PROCEDURE WAS PROLONGED, SINCE THE ROOM WAS UNAVAILABLE AND THE CASE HAD TO BE MOVED TO A DIFFERENT ROOM.