Cook G23735Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002237353), received between Jul 19, 2018 and Jul 22, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Break; Break

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812904 ↗
• MalfunctionJul 5, 2019Break; Break

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764173 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED, DURING A LASER STONE EXTRACTION PROCEDURE, THE COOK® SINGLE-USE HOLMIUM LASER FIBER SNAPPED IN HALF AND ANOTHER FIBER HAD TO BE USED WHICH WORKED AS INTENDED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704339 ↗