VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32548
- Event Type
- Malfunction
- Date Received
- September 13, 2024
- Report Date
- May 12, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- GCM
- PMA / PMN Number
- K193026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SENT FOR A CORRECTION TO THE INITIAL REPORT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6, H11 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE 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.
IT WAS REPORTED THAT THE RIGID VIDEO SCOPE VIDEO IMAGE BECAME WHITE. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
IT WAS REPORTED THAT THE RIGID VIDEO SCOPE VIDEO IMAGE BECAME WHITE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1101244 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |