n.a. 27033ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551074893), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 3, 2019Reflux within Device; Insufficient Flow or Under Infusion; Reflux within Device; Insufficient Flow or Under Infusion

  ALLEGEDLY, DURING AN INCISION OF URETHRA VALVE PROCEDURE, SALINE WAS LEAKING FROM THE RESECTOSCOPE DUE TO A WASHER THAT WAS MISSING; THE SURGEON WAS UNABLE TO MAINTAIN DISTENSION AND REMOVED AND REINSERTED THE SCOPE SEVERAL TIMES TO TROUBLESHOOT THE PROBLEM, WHICH RESULTED IN A URETHRAL TEAR.

  Patient problems: Tissue Damage

  MAUDE report 8759084 ↗