List of Compatible Endoscopes ALT-ProRecalls & reported problems
Olympus Medical Systems Corp. · ALT-PRO AUTOMATIC LEAK TESTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170351761), received between Oct 1, 2021 and Oct 1, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2021Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED TO THE OLYMPUS EMPLOYEE THERE IS A PATIENT INFECTION FOLLOWING THE USE OF AN UNKNOWN SCOPE. THE CUSTOMER STATES THE AUTOMATED ENDOSCOPE LEAK TESTER DID NOT DETECT A LEAK ON THE SCOPE USED WITH THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.
Patient problems: Unspecified Infection
MAUDE report 12562307 ↗InjuryOct 1, 2021Therapeutic or Diagnostic Output Failure
THE CUSTOMER REPORTED TO THE OLYMPUS EMPLOYEE THERE IS A PATIENT INFECTION FOLLOWING THE USE OF AN UNKNOWN SCOPE. THE CUSTOMER STATES THE AUTOMATED ENDOSCOPE LEAK TESTER DID NOT DETECT A LEAK ON THE SCOPE USED WITH THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.
Patient problems: Unspecified Infection
MAUDE report 12562285 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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