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DeRoyal 30-196Recalls & reported problems

Deroyal Industries, Inc. · Esmark · Class 1

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 00749756024532), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionMar 17, 2020Material Fragmentation

    WHITE FLAKING PARTICLES COMING OFF ESMARK PACKAGING WHICH IS PLACED INSIDE BOWL WITHIN CUSTOM PROCEDURE KIT 880119-HAND PACK, LOT #1925636745, UDI#(B)(4). THE USER REPORTED THAT THIS OCCURED ON 3 DIFFERENT DATES: (B)(6) 2020. THE USER REPORTED THAT THE BOWL WAS WIPED OUT BY THE SCRUB NURSE BEFORE POURING IRRIGATION INTO BOWL. THERE WAS NO REPORTED HARM TO THE PATIENT NOR WAS THERE A DELAY TO THE CASE.

    Patient problems: No Patient Involvement

    MAUDE report 9844833 ↗

Other TOURNIQUET, NONPNEUMATIC devices

All TOURNIQUET, NONPNEUMATIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.