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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 ↗

Other Instrument, ultrasonic surgical devices

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Sources and updates

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