Video Adapter OLYMPUS AR-TL08ERecalls & reported problems
Olympus Medical Systems Corp. · AR-TL08E ADAPTER OTV-S5 ROTATABLE .8X · Class 2
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170023972), received between May 9, 2022 and Aug 26, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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
- Detachment of Device or Device Component7
- Failure to Clean Adequately4
- Poor Quality Image4
- Corroded2
- Leak/Splash1
- Loose or Intermittent Connection1
- Material Fragmentation1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454560 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
DURING THE DEVICE EVALUATION, IT WAS OBSERVED THAT A SCREW ON THE VIDEO ADAPTER HAD FALLEN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148088 ↗MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO ADAPTER EXHIBITED A LOOSE SCREW ON CAMERA CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820704 ↗MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE VIDEO ADAPTER FIXING SCREW CAME OFF. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23524040 ↗MalfunctionOct 31, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A SMALL BLACK FRAGMENT FROM THE DEVICE IN THE BASKET ISSUE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435366 ↗MalfunctionOct 15, 2025Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303151 ↗MalfunctionOct 15, 2025Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301427 ↗MalfunctionMay 30, 2025Failure to Clean Adequately; Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118046 ↗MalfunctionMay 30, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE CAMERA HEAD EXPERIENCED A SMALL BLACK FRAGMENT FROM THE DEVICE IN THE BASKET ISSUE DURING A REPROCESSING PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22117139 ↗MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE SCREW CAME OFF. THE ISSUE OCCURRED DURING DEMONSTRATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092138 ↗MalfunctionMay 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE'S SCREW CAME OFF DURING A LAB OR DEMONSTRATION EVENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962867 ↗MalfunctionMay 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21955112 ↗MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCREW OF THE SUBJECT DEVICE CAME OFF. THE ISSUE OCCURRED DURING THE DEMONSTRATION AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942918 ↗MalfunctionMar 27, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21706277 ↗MalfunctionJan 21, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200242 ↗MalfunctionOct 2, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A LENS SURFACE SCRATCHED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355698 ↗MalfunctionJun 4, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING CLEANING AND DISINFECTION, AN EXTERNAL SCREW OF THE CONNECTOR PART WAS LOOSE ON VIDEO ADAPTER. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460115 ↗MalfunctionFeb 14, 2024Corroded; Leak/Splash; Corroded; Leak/Splash
THE CUSTOMER REPORTED THE SUBJECT DEVICE HAD WATER INVASION AND POOR IMAGE QUALITY. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704238 ↗MalfunctionMay 9, 2022No Display/Image; No Display/Image
AS REPORTED FOR THIS ISSUE BY THE OLYMPUS REPRESENTATIVE, THE DEVICE YIELDED NO IMAGE. THERE IS NO HARM TO ANY PATIENT OR PERSONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14341800 ↗
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- DUODENOVIDEOSCOPE TJF-150Olympus Medical Systems Corp. · Endoscopic video imaging system/component, gastroenterology-urology4 deaths413 reports
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- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300Olympus Medical Systems Corp. · Endoscopic Video Imaging System/Component, Gastroenterology-Urology158 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.