VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32674
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Report Date
- April 9, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- GCM
- UDI-DI
- 04042761083492
- PMA / PMN Number
- K193026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. SINCE THE MALFUNCTION WAS NOT CONFIRMED, THE PROBABLE CAUSE COULD NOT BE DETECTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS SUPPLEMENTAL EMDR IS BEING SUBMITTED TO CORRECT THE MANUFACTURING DATE: 1/3/2019H4.
E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRED IMAGE/ BLURRED SPOT IN CENTER RIGHT OF SCREEN. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRED IMAGE/ BLURRED SPOT IN CENTER RIGHT OF SCREEN. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRED IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1430699 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO SCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |