FDA Adverse Event
Malfunction
Summary report: N
VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE
MDR report key: 24912316
·
Received April 17, 2026
Report
- Report Number
- 9610773-2026-03098
- Event Type
- Malfunction
- Date Received
- April 17, 2026
- Report Date
- May 28, 2026
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- UDI-DI
- 04042761075015
- PMA / PMN Number
- K190744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE SHOWED A SCOPE COMMUNICATION ERROR B30. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590728 | 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 |