VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-31436
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Report Date
- December 17, 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
- NO
- 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 CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: CHARGED COUPLED DEVICE (R-UNIT) IS BROKEN AND RESOLUTION IS INADEQUATE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE CHARGED COUPLED DEVICE (R-UNIT) IS BROKEN AND THEREFORE THE RESOLUTION IS INADEQUATE AND 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.
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 RECEIVED FROM CUSTOMER.
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A VIDEO ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564743 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |