VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 17, 2026
Report 9610773-2026-05034 · MDR key 25858342
Device
Product problems
- Crack
- Image Orientation Incorrect
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE PICTURE WAS UPSIDE DOWN DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. ADDITIONALLY, THE DEVICE EVALUATION IDENTIFIED THE FOLLOWING REPORTABLE MALFUNCTIONS: A DENT IN THE OUTER TUBE AND A BROKEN R-UNIT (CHARGE-COUPLED DEVICE). WAS BROKEN. THE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT ESTABLISH WHY THE PICTURE APPEARED UPSIDE DOWN. THE DENT IN THE OUTER TUBE AND THE BROKEN R-UNIT (CHARGE-COUPLED DEVICE) WERE ATTRIBUTED TO A COMPONENT FAILURE. THE DATE OF THE EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE DEVICE'S FIELD PERFORMANCE.