FDA Adverse Event
Malfunction
Summary report: N
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
MDR report key: 24086982
·
Received January 15, 2026
Report
- Report Number
- 9610773-2026-00373
- Event Type
- Malfunction
- Date Received
- January 15, 2026
- Date of Event
- December 19, 2025
- Report Date
- January 15, 2026
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- UDI-DI
- 04042761074971
- PMA / PMN Number
- K111788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
G4: K111788, K190744 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE CUSTOMER ISSUE WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE CUSTOMER'S REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LAPAROSCOPE, GYNECOLOGIC HAD FOGGING AND WAS UNABLE TO FOCUS. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150073 | 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 |