TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
Report
- Report Number
- 9610773-2025-04703
- Event Type
- Malfunction
- Date Received
- July 24, 2025
- Date of Event
- June 26, 2025
- Report Date
- October 23, 2025
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- EWY
- UDI-DI
- 04042761052764
- PMA / PMN Number
- K950076
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
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: D8, G1, G3, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO REGIONAL SERVICE CENTER 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: A COMPONENT FAILURE OF THE LENS. 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 LENS COMES OFF. THE ISSUE WAS IDENTIFIED DURING DEVICE INSPECTION BEFORE USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1343791 | TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE | RIGID OPTICAL LAPAROSCOPE | EWY | OLYMPUS WINTER & IBE GMBH | WA53005A | 04042761052764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |