VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32420
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- August 22, 2024
- Report Date
- December 19, 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
- GG
- 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 A CORRECTION IN PREVIOUS EMDR-17586. CORRECTED FIELD: G3 CHANGED FROM 8/29/2024 TO 10/2/2024.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION IN PREVIOUS EMDR.
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: THE VIDEO CABLE WAS BROKEN. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE VIDEO CABLE WAS BROKEN AND THEREFORE ERROR 216 OCCURS. 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 WAS DISPLAYING A COMMUNICATION ERROR (E216). THE ISSUE WAS IDENTIFIED IN PREPARATION TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS DISPLAYING A COMMUNICATION ERROR (E216). THE ISSUE WAS IDENTIFIED IN PREPARATION TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS DISPLAYING A COMMUNICATION ERROR (E216). THE ISSUE WAS IDENTIFIED IN PREPARATION TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2140832 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |