Olympus 00121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761000130), received between Aug 31, 2023 and Apr 28, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DEVICE EXHIBITED BROKEN FORCEPS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916956 ↗
• MalfunctionJul 26, 2024Break; Break

  IT WAS REPORTED THE GRASPING FORCEPS WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840498 ↗
• MalfunctionOct 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE SCREW CAME LOSE ON THE GRASPING FORCEPS DURING REPROCESSING AND THE GRASPER FELL APART INTO TWO PIECES. THERE WERE NO REPORTS OF HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936788 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE GRASPING FORCEPS, FELL APART INTO TWO PIECES AFTER A SCREW CAME LOOSE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902338 ↗
• MalfunctionAug 31, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE GRASPING FORCEPS HAD A DAMAGED (BENT) TUBE. THE MALFUNCTION WAS IDENTIFIED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661760 ↗