CLICKLINE 33500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551150931), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.

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

• MalfunctionFeb 3, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): DURING OPERATION, THE SURGEON FELT THAT THE HANDLE OF THE TENACULUM FORCEPS WAS NOT MOVING SMOOTHLY. THUS, HE ASKED THE NURSE TO SEPARATE THE INSERT WITH THE HANDLE. THE OUTER SHEATH 33500 WAS THEN FOUND BROKEN AND WAS SNAPPED AT THE PROXIMAL END. THE SURGEON TRIED TO RETRIEVE ALL THE BROKEN PARTS OF THE OUTER SHEATH. FOR THE CASE ON (B)(6), THE SURGEON COULD NOT FIND ALL THE DETACHED PARTS. SINCE SOME OF THE DETACHED PARTS FOR THE CASE ON (B)(6) WERE NOT FOUND, THERE COULD BE A RISK DUE TO FOREIGN BODY LEFT IN PATIENT. ACCORDING TO OUR INFORMATION, NO ADDITIONAL HOSPITALIZATION WAS NECESSARY. THERE IS NOT YET ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE HEALTH IMPACT OR IF ANY OCCURED. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444222 ↗