n.a. 27054G-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551394410), received between Jul 10, 2025 and Jul 10, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING LOOP TIP BROKE OFF INSIDE THE PATIENT. NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470940 ↗
• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING LOOP TIP BROKE OFF INSIDE THE PATIENT. NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470843 ↗