Cook G25296Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002252967), received between Nov 17, 2017 and Mar 30, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE INSIDE THE SCOPE. AN ALTERNATIVE FIBER WAS OPENED AND USED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384842 ↗
• MalfunctionNov 17, 2017Break; Break

  THE AREA REPRESENTATIVE REPORTED THAT THE COOK SINGLE-USE HOLMIUM LASER FIBER WAS BRITTLE. WHEN IT WAS INSERTED INTO THE SCOPE THE FIBER BENT BACK AND BROKE. THIS OCCURRED PRIOR TO PATIENT CONTACT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS PRODUCT ISSUE. A NEW FIBER WAS PUT IN THE LASER AND THE PROCEDURE WAS COMPLETED. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041613 ↗