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Flex-X 11278VURecalls & reported problems

Karl Storz GmbH & Co. KG · Video Uretero-Renoscope, FLEX-X C · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551278239), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 1, 2022Open, Classified

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

    Z-1068-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem

    ALLEGEDLY, DURING A STONE REMOVAL PROCEDURE WITH A FLEX-XC VIDEO URETEROSCOPE, THE PATIENT'S URETER WAS TORN.

    Patient problems: Laceration(s)

    MAUDE report 7708326 ↗

Other Ureteroscope and accessories, flexible/rigid devices

All Ureteroscope and accessories, flexible/rigid devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.