TROCAR INTRODUCER FOR LTF 5 MM SCOPE MAJ-1379Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170316159), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K201832); they may or may not involve this specific model.

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 18, 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.

• InjuryJul 26, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED TO OLYMPUS, NEAR THE END OF THE THERAPEUTIC LAPAROSCOPY, PART OF THE SUBJECT DEVICE WAS DAMAGED. THE SUBJECT DEVICE WAS ATTACHED TO OLYMPUS ENDOSCOPE LTF-S190-5 AND USED AS AN INSERTION AID. A PORTABLE X-RAY DID NOT CONFIRM ANY DEBRIS IN ABDOMINAL CAVITY, NO SHADOWS SEEN. AFTER THE PROCEDURE WAS COMPLETED, A CT SCAN CONFIRMED PIECES FELL INTO THE ABDOMINAL CAVITY. A REOPERATION WAS PERFORMED (B)(6) 2022 AND THE FOREIGN MATERIAL WAS REMOVED. IT IS UNCLEAR WHEN C0R47 WAS USED BY THE CUSTOMER. THE PATIENT WAS DISCHARGED WITHOUT FURTHER ISSUES (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15106218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201832. One submission often covers many models, so check the product and lot details in each record.

• Z-0644-2024 · Nov 20, 2023 · Open, Classified
  OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments