Lone Star 3314-8GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937015508), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.

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

• MalfunctionSep 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED PAN-PROCTOCOLECTOMY, A LONE STAR RETRACTOR AND ELASTIC STAYS WERE USED AS RETRACTION DURING THE PROCEDURE. WHEN REMOVING THE DEVICE, IT WAS NOTICED THAT ONE OF THE HOOKS HAD BECOME DETACHED FROM THE SURGICAL STAY AND ANOTHER WAS BENDING. THEREFORE THE RETRACTORS AND STAYS WERE REMOVED AND A SEARCH OF THE AREA AND PATIENT WAS PERFORMED TO LOCATE THE MISSING HOOK. A SPECIMEN X-RAY WAS PERFORMED IN THEATRE. IT WAS ESTABLISHED THAT THE HOOK WAS NOT IN THE PATIENT. .3314-8G 3MM ELASTIC STAYS 2024-09-0000206.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320865 ↗