Key Surgical Universal Light Handle Cover LHC-201-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849771030591), received between Dec 14, 2018 and Dec 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 18, 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.

• MalfunctionDec 14, 2018Material Integrity Problem; Material Integrity Problem

  SURGICAL LIGHT HANDLE COVER PLACED OVER LIGHT HANDLE PRIOR TO SURGICAL START. INTRAOPERATIVELY, THE SURGEON REACHED FOR THE LIGHT TO CHANGE THE ANGLE. THE LIGHT HANDLE COVER SPLIT AND FELL INTO THE SURGICAL FIELD. THE USER FACILITY REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS POSTOPERATIVELY. NO OTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8166241 ↗
• MalfunctionDec 14, 2018Material Integrity Problem; Material Integrity Problem

  DARK BLUE SOFT PLASTIC PORTION OF THE LIGHT HANDLE COVER SEPARATED FROM LIGHT BLUE HARD PLASTIC BASE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8166036 ↗