Foot Switch MAJ-1243Recalls & reported problems
Olympus Medical Systems Corp. · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170170492), received between Jul 25, 2019 and Jan 13, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Disconnection1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2020Break; Break
DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED IN COMBINATION WITH SONOSURG GENERATOR. IN THE PROCEDURE, AN ABNORMAL NOISE FROM THE GENERATOR OCCURRED AND THE GENERATOR COULD NOT OUTPUT. THE USER EXCHANGED THE SUBJECT DEVICE FOR ANOTHER DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE OUTPUT FAULT OF THE SUBJECT DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9584465 ↗MalfunctionJul 25, 2019Disconnection; Disconnection
DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE WAS USED. AN OUTPUT FAILURE OCCURRED BECAUSE OF DISCONNECTION. THE USER REPLACED THE SUBJECT DEVICE WITH ANOTHER DEVICE AND COMPLETED THE INTENDED PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8824978 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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