Olympus A2421Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761003308), received between Aug 11, 2023 and Aug 11, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211175 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT THE FLEXIBLE ENDOSCOPIC TISSUE MANIPULATION FORCEPS WORKING END WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939773 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THAT THE FLEXIBLE ENDOSCOPIC TISSUE MANIPULATION FORCEPS WORKING END WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939189 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THE GRASPING FORCEPS'S PILER JAWS WERE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524984 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED, THE GRASPING FORCEPS HAD A PIECE ON END OF GRASPER BREAK OFF AT FIRST USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707182 ↗
• MalfunctionOct 17, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE GRASPING FORCEPS, TOOTHED, 5 FR. X 640 MM, FLEXIBLE HAD A BROKEN ITEM - SPECIFICALLY, THE CLOSING MECHANISM ON THE GRASPING FORCEPS FAILED. THE ISSUE OCCURRED DURING RECEIPT INSPECTION WITH NO PROCEDURE INVOLVED, AS AN OUT-OF-BOX FAILURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954558 ↗
• MalfunctionAug 11, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS, THE USE OF THE GRASPING FORCEPS, DURING REMOVAL OF THE STENT PLACED A WEEK EARLIER (URETEROSCOPY) TOOK THE USER SEVERAL ATTEMPTS TO GRASP THE STENT AND ULTIMATELY USED AN OLD OLYMPUS GRASPER TO USE TO REMOVE IT. THOUGH THE PROCEDURE WAS EXTENDED FOR AN UNSPECIFIED AMOUNT OF TIME DURING THE ATTEMPTS AND TO RETRIEVE THE OTHER GRASPER, IT WAS COMPLETED WITHOUT REPORTS OF USER/PATIENT ADVERSE EVENTS. THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA WHICH POSES PATIENT TO LOW RISK FOR HARM/ADVERSE EFFECTS. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, AND THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514561 ↗