VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE
Report
- Report Number
- 9610773-2025-02611
- Event Type
- Malfunction
- Date Received
- April 11, 2025
- Report Date
- November 20, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- PMA / PMN Number
- K190744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, 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, H6, H11. 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: CHIPPED VIDEO CONNECTOR'S TIP, DENTS ON OUTER TUBE, OUTER TUBE BENT, LIGHT GUIDE ADAPTER LOOSED. A DEFINITIVE ROOT CAUSE WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION. THE MOST PROBABLE CAUSE OF COMPLAINT IS 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 PINHOLE IN THE CORD. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1092923 | VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE | RIGID VIDEO LAPAROSCOPE | HET | OLYMPUS WINTER & IBE GMBH | WA50050A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |