VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE
Report
- Report Number
- 9610773-2025-04277
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 16, 2025
- Report Date
- December 3, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- UDI-DI
- 04042761075015
- PMA / PMN Number
- K190744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE COMMUNICATION ERROR B30 WAS DUE TO A COMPONENT FAILURE OF THE UNIVERSAL CABLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
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 HAS SCOPE COMMUNICATION ERROR B30. THE ISSUE OCCURRED SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142390 | VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE | RIGID VIDEO LAPAROSCOPE | HET | OLYMPUS WINTER & IBE GMBH | WA50052A | 04042761075015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |