VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32659
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Date of Event
- August 26, 2024
- Report Date
- December 6, 2024
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- GCM
- UDI-DI
- 04042761083492
- PMA / PMN Number
- K193026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. ADDITIONALLY, DURING INSPECTION FOLLOWING MALFUNCTION WAS IDENTIFIED: R-UNIT BROKEN. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: R-UNIT BROKEN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
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.
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
IT WAS REPORTED, THE SUBJECT DEVICE DISPLAYED PIXELS APPEARS ON THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1502287 | VIDEO-OPTIK "ENDOEYE 3D", 30° | WA50082A | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |