FDA Adverse Event
Malfunction
Summary report: N
HOPKINS TELESCOPE 6°, 18 FR.
MDR report key: 23430635
·
Received October 30, 2025
Report
- Report Number
- 9610617-2025-01953
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Report Date
- June 1, 2026
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- FGA
- PMA / PMN Number
- K232370
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative · 0
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE IS A IMPROPER VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2407938 | HOPKINS TELESCOPE 6°, 18 FR. | HOPKINS TELESCOPE 6°, 18 FR. | FGA | KARL STORZ SE & CO. KG | 27294AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |