Olympus A4825Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761006880), received between Sep 14, 2021 and Sep 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Loose or Intermittent Connection; Component Missing

  The customer reported that one side of the forceps head was loose and had no screw securing it, rendering the device unusable and preventing the procedure from proceeding during a therapeutic hysteroscopy procedure involving an Olympus flexible endoscopic grasping forceps, reusable. The procedure was completed using an Olympus backup device. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884193 ↗
• MalfunctionFeb 19, 2026Component Missing

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388802 ↗
• MalfunctionJul 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE SUBJECT DEVICE WORKING PART DOES NOT CLOSE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587767 ↗
• MalfunctionJul 23, 2025Positioning Failure; Positioning Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577397 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, A PART OF THE WORKING END OF THE GRASPING FORCEPS IS BROKEN. SO, THE CONNECTION TO THE JAWS IS NOT GIVEN AND THAT MEANS IT IS NOT POSSIBLE TO GRASP ANYMORE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787470 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS COULD NOT BE OPENED. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009888 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED, THAT THE GRASPING FORCEPS HAD A FAILURE AT THE WORKING END AS IT WILL NOT OPEN AND CLOSE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897314 ↗
• MalfunctionSep 14, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED UTERUS EXAMINATION, WHEN THE SURGEON REMOVED THE HYSTEROSCOPE, HE NOTICED THAT ONE JAW AT THE DISTAL END OF THE GRASPING FORCEPS WAS BROKEN OFF AND MISSING. HE INSERTED THE HYSTEROSCOPE BACK INTO THE UTERUS TO CHECK IF THE FRAGMENT WAS THERE BUT IT COULD NOT BE LOCATED. AN X-RAY EXAMINATION WAS PERFORMED BUT THE FRAGMENT STILL COULD NOT BE LOCATED AND IT WAS ASSUMED THAT IT WAS FLUSHED OUT WITH THE IRRIGATION FLUID. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12466026 ↗