Olympus A4829Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761006927), received between Jan 4, 2023 and Mar 31, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GRASPING FORCEPS HAD THE SCREW CAME OFF DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742975 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FLEXIBLE ENDOSCOPIC GRASPING FORCEPS HAD SCREW CAME OFF. THE ISSUE WAS IDENTIFIED DURING DEVICE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742428 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED, THE GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE EXHIBITED A BROKEN DISTAL END. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278708 ↗
• MalfunctionDec 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE PATIENT UNDERWENT HYSTEROSCOPIC EXAMINATION AND REMOVAL OF INTRAUTERINE PREGNANCY RESIDUE UNDER GENERAL ANESTHESIA INTUBATION. WHEN PREPARING TO USE THE GRASPING FORCEPS DURING THE SURGERY, IT WAS FOUND THAT IT WAS UNABLE TO CLAMP THE TISSUE. UPON EXAMINATION, IT WAS FOUND THAT THE SMALL SCREW AT THE FRONT END OF THE GRASPING FORCEPS WAS LOOSE AND FELL OFF. DUE TO THE SMALL SIZE OF THE SCREW, IT WAS REPEATEDLY SEARCHED UNDER THE SCOPE AND CONFIRMED THAT NO SMALL SCREW WAS FOUND IN THE PATIENT'S UTERINE CAVITY. THEN, A NEW GRASPING FORCEPS WAS IMMEDIATELY REPLACED TO CONTINUE THE SURGERY AND IT WAS COMPLETED. THE PATIENT'S VITAL SIGNS REMAINED STABLE DURING THE SURGERY, AND THE PROCESS WAS SMOOTH. THE PATIENT RETURNED TO THE WARD SAFELY AFTER THE SURGERY. THE USER CONFIRMED THE MISSING FORCEPS SCREW WAS NOT FOUND WITHIN THE PATIENT¿S UTERINE CAVITY, AND THE EVENT DID NOT REQUIRE AN ADDITIONAL INTERVENTION OR HOSPITALIZATION TO PRECLUDE PERMANENT HARM OR IMPAIRMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341525 ↗
• MalfunctionSep 7, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT WHEN USING A GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE, THE FORCEPS WOULD NOT CLOSE. THE FORCEPS WAS REMOVED, AND IT WAS NOTED THAT ONE OF THE SCREWS WAS LOOSE, AND THE OTHER SCREW WAS MISSING. THE USER INSPECTED THE UTERINE CAVITY UNDER THE HYSTEROSCOPE, AND THE SCREW WAS NOT SEEN. THE STAFF SEARCHED THE AREA BUT DID NOT LOCATE THE MISSING SCREW. THE SHEATH TUBE WAS FLUSHED AFTER THE PROCEDURE AND THERE WERE NO SCREWS FOUND. THE THERAPEUTIC PROCEDURE (ENDOMETRIAL POLYPECTOMY) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS MINIMAL DELAY AND A PATIENT UNDER GENERAL ANESTHESIA AT THE TIME OF THE EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701790 ↗
• MalfunctionJun 28, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE CUSTOMER LATER REPORTED ADDITIONAL INFORMATION REGARDING THE EVENT. THE ORIGINAL PROCEDURE WAS REPORTEDLY A DIAGNOSTIC HYSTEROSCOPY WHICH WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221522 ↗
• MalfunctionMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO OLYMPUS THAT DURING A HYSTEROSCOPY, THE JAWS OF THE GRASPING FORCEPS WERE MISSING (FELL OUTSIDE THE PATIENT¿S BODY). THE USER FINISHED THE CASE WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916538 ↗
• InjuryJan 4, 2023Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, ONE SIDE AT THE DISTAL END OF THE GRASPING FORCEPS BROKE DURING THE PROCEDURE 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 A PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092979 ↗