FDA Adverse Event
Malfunction
Summary report: N
VIDEO URETERO-RENOSCOPE FLEX-XC1
MDR report key: 24039342
·
Received January 12, 2026
Report
- Report Number
- 1221826-2026-00051
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Report Date
- January 21, 2026
- Manufacturer
- KARL STORZ ENDOVISION
- Product Code
- FGB
- UDI-DI
- 04048551428030
- PMA / PMN Number
- K212458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CONCLUSION SUMMARY: INVESTIGATIONAL ACTIVITIES SUGGEST MULTIPLE ROOT CAUSES COULD POTENTIALLY BE RELATED TO IMAGE QUALITY ISSUES. IN AN EFFORT TO FURTHER INVESTIGATE THE POTENTIAL ROOT CAUSES, WE HAVE INITIATED CAPA-25-0042. WE WILL CONTINUE TO TRACK AND TREND IMAGE QUALITY ISSUES. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative · 0
THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT WHEN SCOPE PLUGGED INTO X LINK THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96095 | VIDEO URETERO-RENOSCOPE FLEX-XC1 | VIDEO URETERO-RENOSCOPE FLEX-XC1 | FGB | KARL STORZ ENDOVISION | 091279-06 | 04048551428030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |