NA XOM18-84004HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551025171), received between Apr 16, 2019 and Apr 16, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEVEL 4 ENDOSCOPY PROCEDURE WITH A SHAVER ENT TRICUT BLADE M4 ROTATABLE AND THE BLADE BROKE DURING SURGERY. THE BROKEN PIECE WAS RETRIEVED. ANOTHER STERILMED DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY OR CONSEQUENCE DUE TO THIS EVENT. THE INTENT OF THE PROCEDURE WAS NOT ALTERED BECAUSE OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520933 ↗