DeRoyal 26-011NSRecalls & reported problems
Deroyal Industries, Inc. · Light Handle Cover · Class 2
- 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 00749756024754), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Mechanical Problem1
- Unintended Movement1
Patient problems
- No Known Impact Or Consequence 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 6, 2018Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
THE LIGHT HANDLE COVER FELL DOWN INTO THE STERILE FIELD DURING SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7852574 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.