NA 091271-06Recalls & reported problems
Karl Storz GmbH & Co. KG · Video Uretero-Renoscope FLEX-XC1 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Karl Storz flexible video uretero-renoscope is used to look inside the kidney and ureter. Most of the 50 reports describe image problems — no picture at all, flickering or static-filled video, and optical faults — along with the scope sticking during removal and parts that would not connect or pass laser fiber. Reports mention 17 injuries, mostly minor cuts, and no deaths. There are no recalls naming this device, and reports have nearly doubled in the past year, from 13 to 25.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04048551428009), received between Oct 30, 2023 and Aug 20, 2026 — classified as 17 injuries, 30 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (13 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
- No Display/Image13
- Display or Visual Feedback Problem6
- Erratic or Intermittent Display5
- Physical Resistance/Sticking5
- Misconnection4
- Optical Problem4
- Device Damaged by Another Device2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information7
- Laceration(s)2
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50353224 ↗InjuryJul 31, 2026Complete Blockage
It was reported that while using one of the 091271-01, the surgical team reported an obstruction, and the procedure had to be cancelled. Event date is (b)(6) 2026 - procedure was delayed and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105112 ↗MalfunctionJun 18, 2026Physical Resistance/Sticking
THE FOLLOWING WAS REPORTED: SCOPE COULDN'T PASS LASER FIBER THROUGH CHANNEL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545334 ↗MalfunctionApr 29, 2026Difficult to Remove
THE FLEXIBLE ENDOSCOPE WAS DIFFICULT TO REMOVE FROM THE RENAL CALYX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032319 ↗MalfunctionApr 21, 2026Physical Resistance/Sticking
IT HAS BEEN REPORTED THE LASER FIBER WAS NOT GOOD ON THE WORKING CHANNEL. THEY USED A DIFFERENT SCOPE AND WAS ABLE TO PROCEED, THE REPLACEMENT USED WORKED. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943390 ↗MalfunctionApr 15, 2026No Display/Image
IT HAS BEEN REPORTED, ALL 3 SCOPES WERE USED IN THE SAME CASE. THE FIRST 2 DIDN'T TAKE THE FIBER THROUGH THE INSTRUMENT CHANNEL AND THE 3RD MALFUNCTIONED ELECTRONICALLY AND THE IMAGE STARTED SHOWING INTERFERENCE, DISCOLORED TO GREENS AND PURPLES, AND THEN ULTIMATELY WENT AWAY COMPLETELY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 1221826-2026-00829. 1221826-2026-00830.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887769 ↗MalfunctionApr 6, 2026No Display/Image
IT WAS REPORTED THAT WHEN THE SCOPE PLUGGED IN THERE WAS A WHITE/YELLOW IMAGE SHOWN AND NO PICTURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794595 ↗MalfunctionApr 1, 2026No Display/Image
IT WAS REPORTED THAT THE IMAGE DETERIORATES SIGNIFICANTLY AND THE IMAGE DISAPPEARS DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24759826 ↗MalfunctionMar 6, 2026Mechanical Problem
THE FOLLOWING WAS REPORTED: A 091271-01 FAILED DURING A CASE. HE STATED A LASER GET STUCK WHEN BEING PUT THROUGH THE WORKING CHANNEL. IT GETS STUCK AT THE POINT THE CHANNEL STARTS TO BEND. TOOK THE 10 TRIES TO GET IT TO PASS THROUGH AND THEY WERE ABLE TO COMPLETE THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531369 ↗MalfunctionFeb 10, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE ISSUE WAS THAT THE LASER FIBER WOULD NOT PASS THROUGH THE WORKING CHANNEL. IT WAS GETTING STUCK AT THE JUNCTION POINT WHERE THE WORKING CHANNEL COMES IN AT A 45 DEGREE ANGLE TO THE STRAIGHT PART OF THE WORKING CHANNEL. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR IMPACT DUE TO THIS AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER SCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308259 ↗MalfunctionFeb 10, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THEY COULD NOT THREAD THE WIRE THROUGH ON THIS SCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308258 ↗MalfunctionJan 28, 2026Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THE IMAGE SHOWED INTERFERENCE AND VISUAL ARTIFACTS PRIOR TO PROCEDURE, DURING FUNCTIONAL TESTS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206541 ↗MalfunctionJan 26, 2026Display or Visual Feedback Problem
IT HAS BEEN REPORTED, WHEN SCOPE WAS INITIALLY PLUGGED IN, IT POPPED UP WITH A PINK SCREEN LIKE IT WAS ALREADY INSERTED INTO THE KIDNEY BUT WAS NOT. AFTERCASE, WHEN TROUBLE SHOOTING, IT DID NOT DISPLAY ANY IMAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177721 ↗MalfunctionJan 22, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT FLEX-XC1 091271-06 DURING RIRS PROCEDURES SUDDENLY WENT OUT. THE VIGILANCE CASE INVOLVED 2 PIECES OF THE SAME DEVICE WITH THE SAME LOT NUMBER AS THEY WERE USED DURING THE SAME SURGICAL PROCEDURE. THERE WAS A DELAY OF PROCEDURE OF LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148994 ↗MalfunctionJan 21, 2026Mechanical Problem
THE FOLLOWING WAS REPORTED: THE DEFLECTION MECHANISM BROKE DURING THE PROCEDURE NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24137426 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT "DURING THE PROCEDURE THE DEFLECTION LEVER BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE USER OR PATIENT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23928285 ↗InjuryDec 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE TWO URS DEVICES WERE USED BUT UNFORTUNATELY, THEY DID NOT WORK. BOTH DEVICES HAD BEEN USED ON THE SAME PATIENT AND THE PROCEDURE HAD TO BE ABORTED DUE TO THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851370 ↗InjuryDec 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE TWO URS DEVICES WERE USED BUT UNFORTUNATELY, THEY DID NOT WORK. BOTH DEVICES HAD BEEN USED ON THE SAME PATIENT AND THE PROCEDURE HAD TO BE ABORTED DUE TO THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851339 ↗MalfunctionDec 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT "WANTED TO USE A DISPOSABLE URS, BUT AS SOON AS IT WAS CONNECTED, THE SYSTEM IMMEDIATELY SWITCHED OFF THE LIGHT AND THERE WAS NO IMAGE".NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710228 ↗MalfunctionDec 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE TELESCOPE DIDN'T DISPLAY AN IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707247 ↗MalfunctionDec 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED: THE PICTURE WILL GO IN AND OUT ON SCOPE AND HAS QUITE A BIT OF INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707243 ↗MalfunctionDec 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED: THE PICTURE WILL GO IN AND OUT ON THE SCOPE AND HAS QUITE A BIT OF INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707231 ↗MalfunctionOct 22, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE DEVICE TURNED OFF DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23358827 ↗MalfunctionSep 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THERE WAS DIFFICULTY OF PASSING A LASER FIBER. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044389 ↗MalfunctionSep 10, 2025No Display/Image; No Display/Image
ACCORDING TO THE INFORMATION RECEIVED, WHEN CONNECTED TO THE CONTROL UNIT, IT DID NOT GIVE ANY SIGNAL IMMEDIATELY, EVEN AFTER RESTARTING THE CONTROL UNIT AND SEVERAL RECONNECTION ATTEMPTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23021611 ↗
Other Ureteroscope and accessories, flexible/rigid devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall1,125 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 reports
- 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
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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