OSSEODUO Foot Pedal 1600517Recalls & reported problems
Bien-Air Surgery SA · 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 17630055505245), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended System Motion” (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.
Reports received per month
Most reported problems
Device problems
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Unintended System Motion
After stepping on the foot pedal and releasing the foot, the motor kept on rotating. The magnet of the foot pedal came off its location.No patient was involved in the incident.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927699 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.