NA LB83Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995172572), received between Feb 8, 2023 and Dec 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED VIA MEDWATCH # MW5178603 THAT "ONE OF THE LIGHT HANDLE COVERS FELL OFF INTO THE PATIENT FIELD". NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876684 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD CONTACTING THE PATIENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782945 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD CONTACTING THE PATIENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438809 ↗
• MalfunctionApr 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTER REPORTED THAT THEIR LB83 LIGHT HANDLE COVER FELL INTO THE STERILE FIELD DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864619 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THEIR LB83 LIGHT HANDLE COVER FELL OFF THE HANDLE DURING A PROCEDURE IN THE OR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536895 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR LIGHT HANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD. THE STERILE FIELDS WERE RE-ESTABLISHED, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321154 ↗