N/A (REF 2D5ST)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825017255), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT DURING THE CASE UPON INSERTION, PLASTIC FRAGMENTS BROKE OFF THE END OF THE TROCAR AND ENTERED THE PATIENT'S ABDOMEN. THE 5 MM REPROCESSED TROCAR AND INTRODUCER HAD PIECES OF THE INTRODUCER SPLINTER/FRACTURE OFF WHILE ATTEMPTING TO INTRODUCE IT INTO THE ABDOMEN. AS REPORTED, MOST OF THE LARGER PIECES WERE RETRIEVED AND THERE WERE SOME SMALL ONES THAT COULD NOT BE OBTAINED. THERE IS A THEORETICAL RISK OF FOREIGN BODY REACTION IN THE FUTURE. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE EXTENDED PROCEDURE TIME REPORTED WAS 10 MINUTES TO OBTAIN ALL THE PIECES AS WELL AS INTRODUCE A NEW TROCAR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23834256 ↗