VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
Report
- Report Number
- 9610773-2025-04591
- Event Type
- Malfunction
- Date Received
- July 18, 2025
- Report Date
- January 23, 2026
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- UDI-DI
- 04042761074971
- PMA / PMN Number
- K190744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 501
Narratives
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 FINAL INVESTIGATION. UPDATED FIELDS: D9, H2, H3, H4, H6, H11 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE DEVICE HAS LOOSE LIGHT GUIDE ADAPTOR, BENT LIGHT GUIDE ADAPTOR, DENTS ON OUTER TUBE. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE 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.
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD DISPLAYED IMAGE TOO DARK. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395676 | VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE | LAPAROSCOPE, GYNECOLOGIC | HET | OLYMPUS WINTER & IBE GMBH | WA50042A | 04042761074971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |