Olympus A2500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04042761003483), received between Jun 15, 2018 and Jun 17, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Separation

  THE CUSTOMER RETURNED THE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT THE ENTIRE JAW HAS BROKEN OFF AND IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534324 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THE TIP OF THE SUBJECT DEVICE BROKE OFF AND FELL OFF OUTSIDE THE PATIENT BODY DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948652 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD PIN DID NOT HOLD AND WAS LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894367 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEP EXHIBITED THE CONNECTING PIN BETWEEN THE PULL WIRE AND THE FORCEPS JAW HAD BROKEN OFF, THE OPERATING ELEMENT WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856949 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEPS EXHIBITED THE JAWS AT THE WORKING END WERE COMPLETELY BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502074 ↗
• InjuryJan 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE JAWS OF THE GRASPING FORCEPS BROKE OFF. THE STONE CONCREMENTS IN THE URETER WERE REMOVED WITH THE FORCEPS. NO PARTS REMAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED. REPORTEDLY, 2 GRASPING FORCEPS WERE USED DURING A SINGLE EVENT THAT BROKE OFF. THE FOLLOWING 2 PATIENT IDENTIFIERS FOR BELOW 2 OLYMPUS DEVICES THAT WERE INVOLVED DURING A SINGLE EVENT. 1) PATIENT IDENTIFIER #: (B)(6), GRASPING FORCEPS, 5 FR. SEMI-FLEXIBLE, STANDARD, MODEL-A2500, SN-(B)(6). 2) PATIENT IDENTIFIER #: (B)(6), GRASPING FORCEPS, 5 FR. SEMI-FLEXIBLE, STANDARD, MODEL-A2500, SN-(B)(6) (THIS REPORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475275 ↗
• InjuryJan 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: THE USER CONFIRMS THAT BOTH FORCEPS BROKE DURING THE SAME PROCEDURE. THE PROCEDURE WAS FOR THE RETRIEVAL OF URETERAL STONE. THE FRAGMENT OF THE SUBJECT DEVICE FELL INTO THE URETER. THE PROCEDURE WAS PROLONGED BY 5 MINUTES AND THE PATIENT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THE PROCEDURE WAS COMPLETED WITH DIFFERENT FORCEPS AND THE PROCEDURE DID NOT RESULT IN SERIOUS DETERIORATION OF THE PATIENT'S HEALTH. THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE AND FUNCTION WAS DETERMINED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR COMPLICATIONS DUE TO THE DEVICE MALFUNCTION AND THE PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN. THE PROCEDURE OUTCOME IS THE URETER IS FREE OF STONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475264 ↗
• MalfunctionNov 10, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD WAS DAMAGED. THE TUBE WAS BENT AND HAD BROKEN JAWS. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PROCEDURE INVOLVED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115441 ↗
• MalfunctionSep 28, 2023Break; Break

  THE CUSTOMER REPORTED THAT HIS OLYMPUS GRASPING FORCEPS BROKE DURING REPROCESSING. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835858 ↗
• MalfunctionJul 6, 2023Break; Mechanical Problem; Break; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE GRASPING FORCEPS HAD A BROKEN END. THE ISSUE WAS FOUND DURING REPROCESSING BY A NURSE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264326 ↗
• MalfunctionApr 25, 2023Break; Break

  THE CUSTOMER REPORTED, THE SEMI-FLEXIBLE RIGID GRASPING FORCEPS JAWS ARE BROKEN, HAS A ¿BROKEN WORKING END¿. NO PROCEDURE WAS INVOLVED AS THE REPORTED PROBLEM OCCURRED DURING MANUAL CLEANING, DUE TO IMPROPER HANDLING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812050 ↗
• MalfunctionOct 24, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, WHEN THE SURGEON USED THE GRASPING FORCEPS TO GRAB A URETERAL STONE, THE JAWS AT THE DISTAL END OF THE GRASPING FORCEPS BROKE AND FRAGMENTS FELL INTO THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657196 ↗
• MalfunctionDec 4, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE, THE TIP AT THE DISTAL END OF THE GRASPING FORCEPS BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9409970 ↗
• MalfunctionJun 15, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE, THE GRASPING FORCEPS BROKE. IT IS UNKNOWN WHEN EXACTLY THIS DAMAGE OCCURRED AND WHETHER A FRAGMENT FELL INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED, BUT THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604332 ↗