Olympus A64120ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761010160), received between Nov 8, 2021 and Aug 16, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE INSERT GRIP MECHANISM IS DAMAGED. THE ISSUE WAS FOUND IN PREPARATION FOR USE IN AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560443 ↗
• MalfunctionMay 31, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE JAWS "HIQ+", 5 X 330 MM, FINE TOOTH, FENESTRATED DEVICE IS STUCK IN THE SET DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035668 ↗
• InjuryNov 8, 2021Material Deformation; Unclear Information; Material Deformation; Unclear Information

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO THE BOWEL AND REQUIRED A BOWEL RESECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bowel Perforation; Insufficient Information

  MAUDE report 12769657 ↗