FDA Adverse Event
Malfunction
Summary report: N
HOPKINS TELESCOPE 6°, 18 FR.
MDR report key: 23659217
·
Received November 26, 2025
Report
- Report Number
- 9610617-2025-02154
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Report Date
- May 29, 2026
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- FGA
- UDI-DI
- 04048551233825
- 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
ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. 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. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE ROD LENS CAME OUT DURING THE SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301782 | HOPKINS TELESCOPE 6°, 18 FR. | HOPKINS TELESCOPE 6°, 18 FR. | FGA | KARL STORZ SE & CO. KG | 27294AA | 04048551233825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |