VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32603
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Report Date
- January 15, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- GCM
- UDI-DI
- 04042761083492
- PMA / PMN Number
- K193026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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. HOWEVER, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: POOR IMAGE QUALITY; COMPONENT FAILURE OF R-UNIT (CHARGED COUPLED DEVICE). BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
D2A COMMON DEVICE NAME: RIGID VIDEO LAPAROSCOPE.
IT WAS REPORTED THAT THE SUBJECT DEVICE SWITCHED BETWEEN 2D AND 3D ON ITS OWN, AND WHEN TOUCHED THE CABLE, IT SWITCHED AND MADE NOISE AT THE SAME TIME. WHEN LAST USED, IT SOMETIMES WENT DARK WHEN CONNECTING AND COULD NOT BE SEEN OUT OF RIGHT EYE. THE ISSUE WAS FOUND DURING THE MIDDLE OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
IT WAS REPORTED THAT THE SUBJECT DEVICE SWITCHED BETWEEN 2D AND 3D ON ITS OWN, AND WHEN TOUCHED THE CABLE, IT SWITCHED AND MADE NOISE AT THE SAME TIME. WHEN LAST USED, IT SOMETIMES WENT DARK WHEN CONNECTING AND COULD NOT BE SEEN OUT OF RIGHT EYE. THE ISSUE WAS FOUND DURING THE MIDDLE OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1343626 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ELITE II |