CAMERA HEAD
Report
- Report Number
- 3002808148-2025-07027
- Event Type
- Malfunction
- Date Received
- April 25, 2025
- Date of Event
- April 15, 2025
- Report Date
- July 22, 2025
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- GCJ
- PMA / PMN Number
- K955404
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8; H2; H3; H6 AND H11 CORRECTED FIELDS: E1; NO. 20, WENHUA ROAD, YINING COUNTY, YILI COUNTY, ILI KAZAKH AUTONOMOUS PREFECTURE, XINJIANG UYGUR AUTONOMOUS REGION; E3 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, THE MOST PROBABLE CAUSE TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THAT THE SUBJECT DEVICE CABLE WAS BROKEN, AND THE IMAGE WAS ABNORMAL. THE ISSUE WAS FOUND DURING THE SETUP OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484492 | CAMERA HEAD | CAMERA HEAD | GCJ | SHIRAKAWA OLYMPUS CO., LTD. | OTV-S7H-1D | 7224876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |