GEMINI 7205177Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010251107), received between Apr 30, 2019 and Jul 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Optical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 25, 2023Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LT GUIDE GEMINI DID NOT ADEQUATELY ILLUMINATE, AN ADEQUATE VISION WAS NOT ACHIEVED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393063 ↗
• InjuryApr 30, 2019Overheating of Device

  IT WAS REPORTED THAT A PATIENT WAS BURNED ON THE ABDOMEN (SECOND DEGREE) BECAUSE OF AN OVERHEATING OF THE CABLE. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE AND IF THERE WAS DELAY IN THE PROCEDURE.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 8564732 ↗