OR1 NEO IP, ENH
Received Sep 14, 2023 · Event occurred Nov 30, 2020
Report 9610617-2023-00258 · MDR key 17747007
Device
Generic name
Or1 Neo Ip, Enh
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2546Catalog number
WUIS2546
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
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. EVALUATION: IT WAS DISCOVERED THAT THE RTV MATERIAL USED FOR DIELECTRIC STRENGTH ISOLATION IN THE HIGH VOLTAGE SECTION OF THE POWER SUPPLY HAS NOT PROVIDED ENOUGH INSULATION BETWEEN COMPONENTS. HIGH VOLTAGE ARCHING OCCURRED AND HAS CAUSED THE POWER SUPPLY TO BURN AND MALFUNCTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED POWER FAILURE LEADS TO THE DEVICE STOPPING WORKING DURING PROCEDURE. HOWEVER, NO HARM OCCURRED TO THE PATIENT, USER OR THIRD PARTY.