n.a. 28160KD-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551395523), received between Dec 2, 2025 and Dec 2, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjuryDec 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A CUTTING LOOP WAS BROKEN DURING SURGERY, PART OF THE LOOP INCLUDING THE CURVED TIP WAS STUCK INSIDE THE PATIENT'S UTERUS, HAD TO REMOVE IT UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BUT THE CASE WAS DELAYED ABOUT AN HOUR AS WE HAD TO SEARCH FOR THE MISSING PART OF THE CUTTING LOOP EVERYWHERE AND EVENTUALLY HAD TO DO X-RAY AND REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 23700307 ↗
• InjuryDec 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A CUTTING LOOP WAS BROKEN DURING SURGERY, PART OF THE LOOP INCLUDING THE CURVED TIP WAS STUCK INSIDE THE PATIENT'S UTERUS, HAD TO REMOVE IT UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BUT THE CASE WAS DELAYED ABOUT AN HOUR AS WE HAD TO SEARCH FOR THE MISSING PART OF THE CUTTING LOOP EVERYWHERE AND EVENTUALLY HAD TO DO X-RAY AND REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 23700306 ↗