VIDEO-OPTIK "ENDOEYE 3D", 30°
Report
- Report Number
- 9610773-2024-32289
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Report Date
- February 3, 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 EVALUATION OF THE EVENT 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. UPDATED FIELDS: D8, D9, H2, H3, H4, H6, H11 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED FOR THE REPORTED MALFUNCTION. THE MOST PROBABLE ROOT 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 HAD A SCRATCH ON THE COVER GLASS (DISTAL END) AND THE VIDEO IMAGE WAS BLURRED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245889 | VIDEO-OPTIK "ENDOEYE 3D", 30° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50082A | 04042761083492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |