Olympus WA02943ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761029537), received between Aug 9, 2022 and Apr 30, 2025 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Component Missing; Component Missing

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937238 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED, THE RIGID URETEROSCOPE EXHIBITED BROKEN NAIL. THE ISSUE OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750211 ↗
• InjurySep 24, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED DURING A THERAPEUTIC EXAMINATION OF THE URETER PRIOR TO RETROGRADE INTRARENAL SURGERY (RIRS)/URETEROSCOPY WITH LASER LITHOTRIPSY FOR KIDNEY STONE, THERE WAS A PERFORATION OF THE URETER WHILE USING THE RIGID URETEROSCOPE. THE PROCEDURE WAS ABANDONED WHEN THE URETER WAS SEEN TO BE PERFORATED. A DOUBLE-J STENT WAS PASSED. THE PATIENT SUBSEQUENTLY DEVELOPED A URINOMA AND SEPTICEMIA BUT REFUSED TREATMENT AT THE CURRENT FACILITY. THE PATIENT SOUGHT FURTHER TREATMENT FROM AN INTERVENTIONAL RADIOLOGIST TO DRAIN THE URINOMA. HE WENT TO ANOTHER HOSPITAL AND WAS PLACED ON OXYGEN AND DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND PLEURAL EFFUSION. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), HAD FOUR SURGERIES INCLUDING A PERCUTANEOUS NEPHROSTOMY. THIS WAS INFORMED TO THE CUSTOMER BY THE UROLOGIST IN THAT HOSPITAL. THE CUSTOMER'S UROLOGIST VISITED THE PATIENT A COUPLE OF TIMES. THE OPINION OF THE UROLOGIST WAS THAT THE TIP OF THE OLYMPUS SEMI RIDGED URETEROSCOPE IS SHARP, NOT BEVELED, AND THIS IS DANGEROUS BECAUSE IT CAN PERFORATE THE URETER VERY EASILY. THE SCOPE HAS NOT BEEN USED SINCE THAT INCIDENT.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Perforation; Pleural Effusion; Sepsis; Unspecified Infection; Unspecified Kidney or Urinary Problem

  MAUDE report 20293390 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID URETEROSCOPE'S TIP OF THE COVER GLASS WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309747 ↗
• MalfunctionJan 24, 2023Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED. THE NURSE DROPPED THE DEVICE AND DAMAGED THE LENS. THE INTENDED PROCEDURE WAS A THERAPEUTIC TRANSURETHRAL LITHOTRIPSY (TUL) SURGERY. THERE WAS NO DELAY TO THE PROCEDURE AND THE SURGERY WAS COMPLETED USING A DIFFERENT SCOPE. IT WAS FURTHER NOTED THAT THE SCOPE IS USED TWO TO THREE TIMES A MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231363 ↗
• InjuryAug 9, 2022Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED DURING A PROCEDURE, THE SHAFT OF THE RIGID ENDOSCOPE BENT AND CAUSED A URETERIC PARTIAL THICKNESS INJURY. THE SURGEON WAS HAVING DIFFICULTY AND NOTED A SUBMUCOSAL FLAP INJURY IN THERE URETERAL WALL AND REMOVED THEN ENDOSCOPE. AFTER THE ENDOSCOPE WAS REMOVED, IT WAS IDENTIFIED AS BENT. THE SURGEON TRIED TO REINSERT THE ENDOSCOPE BUT COULD NOT AND COMPLETED THE PROCEDURE WITH A SIMILAR DEVICE. THERE WAS A 'SLIGHT' DELAY IN THE PROCEDURE TO ALLOW FOR A NEW ENDOSCOPE SET UP. THE SURGEON PLACED A STENT BECAUSE OF THE INJURY AND WILL FOLLOW-UP IN FOUR WEEKS TO REMOVE THE STENT. THE PATIENT HAD SOME HEMATURIA POST-OPERATIVELY WHICH IS CONSISTENT PER THE PROCEDURE AND THE INJURY DID NOT CHANGE THE PATIENT'S COURSE OF MEDICATION POST-OPERATIVELY.

  Patient problems: Laceration(s)

  MAUDE report 15195531 ↗