OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; LAPAROSCOPE, GYNECOLOGIC
|
Back to Search Results |
|
Model Number WA50042A |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation, and the customer¿s allegation was not confirmed as the image issue was not seen after four hours.The following non-reportable malfunctions were found during the device evaluation: the unit was damaged in multiple places.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
|
|
Event Description
|
The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable had the image color occasionally turn green and the light guide hose was cracked.The issue was found during preparation for use.There were no reports of patient harm.
|
|
Search Alerts/Recalls
|
|
|