n.a. 26173FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551098004), received between Mar 2, 2026 and Mar 2, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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.

• InjuryMar 2, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "WHEN THE SURGEON OPENS THE RETRACTOR AND PLACES IT NEAR THE LIVER, IF IT IS MOVED, THE BRANCHES OF THE RETRACTOR SHIFT AND DAMAGE THE ORGAN." DUE TO A POSSIBLE DAMAGE OF THE LIVER, THIS CASE IS DEEMED REPORTABLE. NO FURTHER DETAILS REGARDING THE NATURE OF THE INJURY (SEVERITY) ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24491917 ↗
• InjuryMar 2, 2026Mechanical Problem

  THE FOLLOWING WAS REPORTED: "WHEN THE SURGEON OPENS THE RETRACTOR AND PLACES IT NEAR THE LIVER, IF IT IS MOVED, THE BRANCHES OF THE RETRACTOR SHIFT AND DAMAGE THE ORGAN." DUE TO A POSSIBLE DAMAGE OF THE LIVER, THIS CASE IS DEEMED REPORTABLE. NO FURTHER DETAILS REGARDING THE NATURE OF THE INJURY (SEVERITY) ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24491913 ↗