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DeRoyal 89-10044Recalls & reported problems

Deroyal Industries, Inc. · C-SECTION PACK · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756980081), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property 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 16, 2026.

Most reported problems

Device problems

  • Electrical /Electronic Property Problem1
  • Failure to Power Up1
  • Power Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 26, 2019Electrical /Electronic Property Problem; Failure to Power Up; Power Problem; Electrical /Electronic Property Problem; Failure to Power Up; Power Problem

    THE ELECTROSURGICAL PENCIL THAT WAS PACKAGED IN A CONVENIENCE KIT WOULD NOT WORK. AFTER CHECKING THE MACHINE TO ENSURE IT WAS WORKING, A NEW PENCIL WAS OPENED AND WORKED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9122465 ↗

Other Kit, surgical instrument, disposable devices

All Kit, surgical instrument, disposable devices →

Sources and updates

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