n.a. 27056LBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551078853), received between Jul 22, 2024 and Jul 22, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Insufficient Device Problem Information; Failure to Clean Adequately; Insufficient Device Problem Information; Failure to Clean Adequately

  IT WAS REPORTED THAT AN OLD, DRY BLOOD CLOT (FROM A PREVIOUS PATIENT) APPEARED TO HAVE ENTERED THE CURRENT PATIENT'S BLADDER THROUGH THE HANDPIECE WHEN A SHEATH WAS INSERTED. POST OPERATIVE BLOODS FOR BLOOD BORNE VIRUS WERE TAKEN. ADDITIONAL/ PROLONGED HOSPITALIZATION WAS REQUIRED. ALTHOUGH IT CAN BE ASSUMED THAT THE INSTRUMENT IS NOT THE CAUSE OF THE TRANSFERRED RESIDUES, THE CASE IS CLASSIFIED AS REPORTABLE AS A PRECAUTIONARY MEASURE.

  Patient problems: Insufficient Information

  MAUDE report 19795104 ↗