Olympus A4826Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04042761006897), received between Jun 27, 2023 and Mar 19, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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.

• MalfunctionMar 19, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640039 ↗
• InjurySep 18, 2023Mechanical Problem; Mechanical Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, REPORTED THREE THE SCISSORS, 5 FR., SEMIFLEXIBLE DEMO SETS SENT INTO FORTH VALLEY FOR THE CONSULTANT TO TEST THE SHEATH AND INSTRUMENTS. THE FIRST TRAY, SCISSORS WERE BLUNT, TO THE POINT THAT THEY WEREN¿T ABLE TO BE USED. THIS EVENT WAS DETECTED ONCE PATIENT WAS ON TABLE ASLEEP AND DELAYED THE HYSTEROSCOPE BIOPSY PROCEDURE BY 30 MINUTES. IT WAS FURTHER NOTED, THEY USED THE BIOPSY GRASPERS, WHICH TOOK A SUBSTANTIAL AMOUNT OF TIME. THE TIME DELAY LED TO THE LAST PATIENT BEING CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS (B)(6) TO CAPTURE THE MULTIPLE INSTANCES WHERE PATIENT PROCEDURES WERE DELAYED. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) FOR THE FIRST TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769916 ↗
• InjurySep 18, 2023Mechanical Problem; Mechanical Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, REPORTED THREE THE SCISSORS, 5 FR., SEMIFLEXIBLE DEMO SETS SENT INTO FORTH VALLEY FOR THE CONSULTANT TO TEST THE SHEATH AND INSTRUMENTS. THE SECOND SET, SCISSORS WERE MISSING A BLADE, SO NOT USEABLE AND NO BUNGS ON THE SET. IT WAS FURTHER NOTED, THIS EVENT OCCURRED DURING PREPARATION FOR USE, THE KIT WAS OPENED AS PATIENT CAME IN ANESTHETIZED AND THE HYSTEROSCOPE BIOPSY PROCEDURE WAS DELAYED BY 30 MINUTES. THEY USED THE BIOPSY GRASPERS, WHICH TOOK A SUBSTANTIAL AMOUNT OF TIME. THE TIME DELAY LED TO THE LAST PATIENT BEING CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS (B)(6) TO CAPTURE THE MULTIPLE INSTANCES WHERE PATIENT PROCEDURES WERE DELAYED. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) FOR THE SECOND TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769882 ↗
• InjurySep 18, 2023Mechanical Problem; Mechanical Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, REPORTED THREE THE SCISSORS, 5 FR., SEMIFLEXIBLE DEMO SETS SENT INTO FORTH VALLEY FOR THE CONSULTANT TO TEST THE SHEATH AND INSTRUMENTS. THE THIRD SET, SCISSORS WERE MISSING A BLADE, SO NOT USEABLE AND NO BUNGS ON THE SET. IT WAS FURTHER NOTED, THIS EVENT OCCURRED DURING PREPARATION FOR USE, THE KIT WAS OPENED AS PATIENT CAME IN ANESTHETIZED AND THE HYSTEROSCOPE BIOPSY PROCEDURE WAS DELAYED BY 30 MINUTES. THEY USED THE BIOPSY GRASPERS, WHICH TOOK A SUBSTANTIAL AMOUNT OF TIME. THE TIME DELAY LED TO THE LAST PATIENT BEING CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS (B)(6) TO CAPTURE THE MULTIPLE INSTANCES WHERE PATIENT PROCEDURES WERE DELAYED. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) FOR THE THIRD TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769829 ↗
• MalfunctionJun 27, 2023Break; Mechanical Problem; Break; Mechanical Problem

  THE PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210648 ↗