ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3D (REF N4501744)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Quick summary
This Olympus Endoeye Flex 3D videoscope is a bendable 3D video scope used in endoscopic procedures. Its 186 reports include no deaths and no injuries. Many describe peeling adhesive, no image or no 3D image, communication errors, and a bending section that cannot be controlled. No recalls name this device, and there are no reports in the last 12 months, compared with 4 in the prior 12 months.
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
- 186
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 04953170434938), received between Jul 17, 2020 and Apr 4, 2025 — classified as 186 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (61 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
- Peeled/Delaminated61
- No Display/Image44
- Communication or Transmission Problem32
- Poor Quality Image26
- Degraded17
- Break5
- Component Missing4
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions185
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773008 ↗MalfunctionNov 21, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE EXHIBITED ERROR CODE B30 AND WAS UNABLE TO RECEIVE THREE DIMENSIONAL IMAGES. THE ISSUE OCCURRED DURING RECEIPT INSPECTION OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747187 ↗MalfunctionNov 12, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE EXHIBITED NO IMAGE WHEN CONNECTING WITH THE SLAVE BOARD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663097 ↗MalfunctionNov 7, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THAT THERE WAS NO IMAGE AND A SCOPE COMMUNICATION ERROR CODE WHEN USING THE DEFLECTABLE VIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION FOR USE OF A THERAPEUTIC LAPAROSCOPIC SURGERY, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20626871 ↗MalfunctionOct 31, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE ADHESIVE DETERIORATED ON THE DISTAL END OF THE VIDEO SCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579872 ↗MalfunctionOct 28, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE FLEX DEFLECTABLE VIDEOSCOPE HAD A B30 ERROR CODE. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550803 ↗MalfunctionOct 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE ENDOEYE FLEX VIDEOSCOPE WAS NOT PROJECTING THE 3D IMAGE. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC HIGH ANTERIOR RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A DELAY OF 10 MINUTES DUE TO THE TIME IT TOOK TO SWITCH THE DEVICE WHICH RESULTED IN AN ANESTHETIC EXTENSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519278 ↗MalfunctionOct 22, 2024Mechanical Problem; Mechanical Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED DAMAGE ON THE UP/DOWN SPROCKET SO THE BENDING SECTION CANNOT BE CONTROLLED AT ALL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509642 ↗MalfunctionOct 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE EXHIBITED A B30 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20506596 ↗MalfunctionOct 16, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VIDEOSCOPE EXHIBITED IMAGES DISAPPEARING AND ERROR MESSAGES B30 (SCOPE COMMUNICATION ERROR) AND E216 (IMAGE OCCURRENCE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20465133 ↗MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING ON THE ADHESIVE OF THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464775 ↗MalfunctionOct 15, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A THERAPEUTIC CHOLECYSTECTOMY PROCEDURE, THE DEFLECTABLE VIDEOSCOPE SCREEN WENT BLACK AND AN ERROR B30 OCCURRED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452528 ↗MalfunctionOct 14, 2024Output Problem; Output Problem
IT WAS REPORTED THE DEFLECTABLE VIDEOSCOPE WAS RANDOMLY TAKING PICTURES ALL BY ITSELF AFTER IT WAS PLUGGED IN DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS PROCEEDED AFTER CONNECTING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436704 ↗MalfunctionOct 10, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED, THE DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING OF THE LIGHT GUIDE LENS ADHESIVE. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421180 ↗MalfunctionOct 9, 2024Poor Quality Image; Detachment of Device or Device Component; Poor Quality Image; Detachment of Device or Device Component
THE EVENT OCCURRED ON THE (B)(6) 2024, BEFORE PROCEDURE WITH NO PATIENT INVOLVEMENT. THERE WAS NO HARM/INJURY OR INFECTION TO THE PATIENT/OPERATOR. THE IMAGE WAS PINK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410256 ↗MalfunctionOct 8, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE EXHIBITED PEELED ADHESIVE OF THE TIP OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20404442 ↗MalfunctionOct 7, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE ENDOEYE 3D FLEX VIDEOSCOPE DID NOT DISPLAY AN IMAGE DURING PREPARATION FOR USAGE IN AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20390336 ↗MalfunctionOct 2, 2024No Display/Image; Peeled/Delaminated; No Display/Image; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE DEFLECTABLE VIDEOSCOPE HAD NO IMAGE DUE TO DAMAGE ON THE CHARGED COUPLED DEVICE UNIT, NO IMAGE DUE TO ELECTRICAL CONTACT OF THE VIDEO CONNECTOR BEING SHAVED, AND THE OBJECTIVE LENS ADHESIVE WAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355938 ↗MalfunctionSep 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS LEAKING. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334554 ↗MalfunctionSep 27, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE¿S ADHESIVE AROUND THE OBJECTIVE LENS WAS PEELED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321360 ↗MalfunctionSep 25, 2024Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE WAS LEAKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305869 ↗MalfunctionSep 25, 2024Degraded; Degraded
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DEFLECTABLE VIDEOSCOPE EXHIBITED DETERIORATION OF THE ADHESIVES OF THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304694 ↗MalfunctionSep 25, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED A DETERIORATION OF THE GLUES ON THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301312 ↗MalfunctionSep 20, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE DEFLECTABLE VIDEOSCOPE DISPLAYED NO IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE UNSPECIFIED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268637 ↗MalfunctionSep 16, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE HAD EXHIBITED PEELING OF THE ADHESIVE PART OF THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233658 ↗
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
- 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
- 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.