N/A FC1SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816728020202), received between Aug 6, 2018 and May 27, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT THE LIGHT CORD WAS PLUGGED INTO A STRYKER L11 LIGHT SOURCE AND BECAME VERY HOT AFTER ONLY 30 MINUTES OF BEING PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091106 ↗
• MalfunctionJan 3, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072928 ↗
• MalfunctionJun 11, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, WHILE USING THE DEVICE THE PATIENT EXPERIENCED SECOND DEGREE BURNS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 11983124 ↗
• MalfunctionAug 15, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED DURING A HIP REPLACEMENT PROCEDURE, THE FIBER OPTIC CABLE MAY HAVE BEEN PLACED ON THE DRAPE OF THE PATIENT. DURING USE, THE TEMPERATURE OF THE FIBER OPTIC CORD FELT HOT AND LEFT A BURN MARK ON THE DRAPE. THE CASE WAS COMPLETED WITHOUT INCIDENT OR PRODUCT MALFUNCTION. THERE WAS NO PATIENT INJURY INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784680 ↗
• MalfunctionAug 6, 2018Use of Device Problem; Use of Device Problem

  DURING A HIP REPLACEMENT PROCEDURE, IT WAS OBSERVED THAT THE DRAPE HAD A BURN MARK WHERE THE FIBER OPTIC CABLE HAD BEEN RESTING UPON IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7755286 ↗