Cook G25298Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002252988), received between Sep 23, 2020 and Feb 22, 2022 — 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. 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.

• MalfunctionFeb 22, 2022Break; Break

  AS REPORTED, A COOK® MULTI-USE HOLMIUM LASER FIBER DID NOT WORK UPON ITS SECOND USE. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS BODY. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE ON (B)(6) 2022, THE TIP WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577455 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573956 ↗