n.a. 27051XARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551078228), received between Apr 24, 2025 and Apr 23, 2026 — 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.

• MalfunctionApr 23, 2026Optical Obstruction

  IT WAS REPORTED THAT, FOLLOWING A DISCUSSION WITH THE OPERATING ROOM TEAM, THE RESECTOSCOPE WAS NOT USED DUE TO A VISION ISSUE. SPECIFICALLY, THE FOLLOWING ASSEMBLY: 30° OPTIC, REF. 27325 BA RESECTION HANDLE, REF. 27040E0 SHEATH, REF. 27051XA IRRIGATION SHEATH, REF. 27051PL DOES NOT ALLOW THE OPTIC TO BE FLUSH WITH THE EDGE OF THE SHEATH, RESULTING IN A TRUNCATED IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-906, CROSS REFERENCE MDR 9610617-2026-907, CROSS REFERENCE MDR 9610617-2026-909.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967490 ↗
• MalfunctionApr 24, 2025Break; Break

  THEY USED THE PRODUCT NOT EVEN 3 MINUTES AND IT BROKE IN HALF - PRIOR MEDICAL PROCEDURE THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. ACCORDING TO THE NEW RECEIVED INFORMATION ON 2025-04-07 THE SURGEON WAS ABLE TO DO PART OF THE SURGERY BUT NOT AS HE WOULD HAVE LIKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900440 ↗