FDA Adverse Event
Malfunction
Summary report: N
VIDEO URETERO-RENOSCOPE FLEX-XC1
MDR report key: 24779187
·
Received April 3, 2026
Report
- Report Number
- 1221826-2026-00727
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Report Date
- April 6, 2026
- Manufacturer
- KARL STORZ ENDOVISION
- Product Code
- FGB
- UDI-DI
- 04048551428023
- PMA / PMN Number
- K212458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Additional Manufacturer Narrative · 0
THIS MDR 1221826-2026-727 WAS FILED IN ERROR, DUPLICATE TO 1221826-2026-00651. UPCOMING INVESTIGATION AND SUPPLEMENTALS WILL ALL BE DOCUMENTED IN 1221826-2026-00651. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED DISTORTION OF DIGITAL IMAGE, COLOR IRREGULARITY OF IMAGE, LINES ACROSS IMAGE, INTERMITTENT LOSS OF IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838301 | VIDEO URETERO-RENOSCOPE FLEX-XC1 | VIDEO URETERO-RENOSCOPE FLEX-XC1 | FGB | KARL STORZ ENDOVISION | 091279-01 | 202511261 | 04048551428023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |