NA 242388Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705028832), received between Jul 27, 2022 and May 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE LIGHT GUIDE, OLYMPUS - ACMI 5.0MM X 4.0M DEVICE BROKE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243245 ↗
• MalfunctionJul 27, 2022Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE LIGHT GUIDE OLYM-ACMI_5.0MMX4.0M DEVICE WAS NOT PRODUCING ENOUGH LIGHT TO SEE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE EPOXY POTTED END WAS CRASHED AND BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH ONE MINUTE OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114426 ↗