n.a. 091279-01Recalls & reported problems
Karl Storz GmbH & Co. KG · Video Uretero-Renoscope FLEX-XC1 · Class 2
Quick summary
This Karl Storz FLEX-XC1 video uretero-renoscope, a thin scope used to look inside the urinary tract, has 116 adverse event reports on file. Most describe the screen going blank or flickering during use, and the reports mention no negative impact on health. The reports include no deaths and no injuries, and the number of reports rose from 22 to 94 over the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 118
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 04048551428023), received between Dec 10, 2024 and Sep 2, 2026 — classified as 116 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (40 reports).
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.
Reports received per month
Most reported problems
Device problems
- Erratic or Intermittent Display40
- No Display/Image37
- Physical Resistance/Sticking13
- Display or Visual Feedback Problem10
- Break5
- Output Problem5
- Poor Quality Image5
- Positioning Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570261 ↗MalfunctionSep 2, 2026Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570258 ↗MalfunctionSep 2, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570255 ↗MalfunctionSep 2, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570251 ↗MalfunctionSep 2, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570246 ↗MalfunctionAug 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432759 ↗MalfunctionAug 21, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376913 ↗MalfunctionAug 14, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261809 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146087 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146086 ↗MalfunctionJul 31, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105111 ↗MalfunctionJul 27, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017026 ↗OtherJul 27, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017024 ↗MalfunctionJul 27, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017023 ↗OtherJul 27, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017020 ↗MalfunctionJun 23, 2026Erratic or Intermittent Display
ITS BEEN REPORTED THE SCOPE HAD TEMPORARY SIGNAL LOSS AND RETURNS TO DASHBOARD. LINE STATIC INTERFERENCE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597676 ↗MalfunctionJun 18, 2026No Visual Prompts/Feedback
IT WAS REPORTED THAT A BLUE DASHBOARD OCCURED AND A SCREEN SIGNAL LOST. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545345 ↗MalfunctionJun 16, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT LASER FIBER DID NOT GO THRU THE WORKING CHANNEL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522766 ↗MalfunctionJun 9, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT INTERMITTENT IMAGE FAILURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447591 ↗MalfunctionJun 9, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT INTERMITTENT IMAGE FAILURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447590 ↗MalfunctionJun 9, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PROCEDURE, THE LASER FIBER WOULD NOT ADVANCE THROUGH UNIT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447474 ↗MalfunctionJun 1, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE SCOPE WOULDN'T SLIDE THROUGH CHANNEL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355851 ↗MalfunctionJun 1, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE PHYSICIAN, WAS UNABLE TO PASS LASER FIBER THROUGH THE WORKING CHANNEL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351933 ↗MalfunctionJun 1, 2026Output Problem
IT WAS REPORTED THAT THEY HAD AN INTERMITTENT SIGNAL AND A SWITCH TO ANOTHER SCOPE WAS NECESSARY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351932 ↗MalfunctionMay 22, 2026Erratic or Intermittent Display
ITS BEEN REPORTED THE IMAGE ON THE SCOPE WAS GOING IN AND OUT DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR:---1221826-2026-01152.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25259414 ↗
Other Ureteroscope and accessories, flexible/rigid devices
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- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- Flex-X / IMAGE 1 S 11278VSUKarl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid2 recalls2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.