DeRoyal 89-10537Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756364119), received between May 15, 2023 and May 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ERROR DISPLAYED ONCE PLUGGED INTO ELECTRICAL SURGICAL UNIT MACHINE "CHECK INSTRUMENT, MONO 2 HANDSWITCH PRESSED, RELEASE SWITCH, IF ISSUE PERSISTS, REPLACE INSTRUMENT" AND HANDPIECE NON-OPERATIONAL. ANOTHER HANDPIECE WAS USED ON SECONDARY ESU IN ROOM FOR CASE. THIS FUNCTIONING HANDPIECE WAS THEN TESTED ON THE FIRST ESU MACHINE AT END OF CASE TO CONFIRM THAT IT WAS A SINGULAR HANDPIECE ISSUE AND WORKED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929670 ↗
• MalfunctionMay 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CAUTERY PENCIL FAILED. HAD TO OPEN NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929569 ↗