ACS CDGL10ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072046116), received between Aug 7, 2019 and Aug 7, 2019 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2019Contamination of Device Ingredient or Reagent

  CMC GYN LAPAROSCOPY CDGL 10E STERILE SURGICAL SUPPLY PACK OPEN. FOUND UNIDENTIFIED CONTAMINANT IN RAYTEC CONTAINED WITHIN PACK (POSSIBLE LINT). ENTIRE TABLE WAS SET UP AND TRAYS CHECKED, SO WE HAD TO DISPOSE OF THE WHOLE THING AND START OVER. PATIENT WAS IN THE ROOM, UNDER ANESTHESIA. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869730 ↗