Olympus WA03300ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761082297), received between Jan 10, 2020 and Mar 19, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, WHILE USING THE LIGHT CABLE, THE TIP OF THE CAMERA HEAD WAS FOUND TO BE SCORCHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932524 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT ONE DAY AFTER A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE A BURN OF APPROX 1.04 INCHES WAS DISCOVERED ON THE PATIEN'S THIGH. A SKIN GRAFT WAS PERFORMED AT THE LOCATION OF THE BURN INJURY AND THE PATIENT WAS DISCHARGED FROM HOSPITAL.

  Patient problems: Burn(s)

  MAUDE report 16022547 ↗
• MalfunctionMar 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  OLYMPUS WAS INFORMED BY THE STERILE PROCESSING MANAGER AT THE USER FACILITY THAT THE LIGHT-GUIDE CABLE WILL BE RETURNED FOR REPAIR FOR A REPORTED ¿CLOSE TO THE CONNECTOR THE OUTER COVERING CLOSE TO THE LIGHT FIBERS IS RIPPED¿ THAT WAS OBSERVED DURING REPROCESSING. THE DEVICE WAS RETURNED TO OLYMPUS; THE SERVICE EVALUATION FOUND THE OUTER PROTECTIVE COVER OF THE CABLE WAS TORN AND PULLED APART FROM THE LIGHT GUIDE ADAPTER SIDE WITH EXPOSED LIGHT FIBERS. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13728480 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT WHEN THE DRAPE WAS REMOVED FROM THE PATIENT AFTER A SUCCESSFULLY COMPLETED THERAPEUTIC TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A BURN INJURY OF APPROX. 22.5-23.5 MM ON ONE LEG. IT IS ASSUMED THAT THE BURN OCCURRED WHEN THE LIGHT-GUIDE CABLE WAS SHORTLY PLACED ON THE PATIENT AFTER IT HAD BEEN REMOVED FROM THE SCOPE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister; Burn(s)

  MAUDE report 11371886 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE PATIENT SUSTAINED BURN INJURIES WHEN THE LIGHT-GUIDE CABLE WAS REMOVED FROM THE OPTICAL TUBE AND PLACED ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT.

  Patient problems: Burn(s)

  MAUDE report 11235093 ↗
• InjuryJan 10, 2020Overheating of Device; Overheating of Device

  ON DECEMBER 17, 2019 THE MANUFACTURER RECEIVED MEDWATCH REPORT (MW5091350) THAT STATES, "DURING CYSTOSCOPY PROCEDURE, ROOM STAFF NOTED THEY SMELLED SOMETHING BURNING AND PATIENT MOANED IN PAIN SO CYSTOSCOPY SCOPE WAS REMOVED. THE END OF THE SCOPE WAS BLACKENED AND SCOPE BODY ALSO HAD LIGHTER COLORED BLACK MARKS ON SHAFT. THIS SCOPE WAS USED WITH AN OLYMPUS LIGHT CABLE AND A KARL STORZ LIGHT SOURCE."THIS REPORT IS FOR 2 OF 2 DEVICES.

  Patient problems: No Information

  MAUDE report 9577977 ↗
• InjuryJan 10, 2020Thermal Decomposition of Device; Material Discolored; Overheating of Device

  ON DECEMBER 17, 2019 THE MANUFACTURER RECEIVED MEDWATCH REPORT (MW5091350) THAT STATES, "DURING CYSTOSCOPY PROCEDURE, ROOM STAFF NOTED THEY SMELLED SOMETHING BURNING AND PATIENT MOANED IN PAIN SO CYSTOSCOPY SCOPE WAS REMOVED. THE END OF THE SCOPE WAS BLACKENED AND SCOPE BODY ALSO HAD LIGHTER COLORED BLACK MARKS ON SHAFT. THIS SCOPE WAS USED WITH AN OLYMPUS LIGHT CABLE AND A KARL STORZ LIGHT SOURCE. AS PART OF OUR INVESTIGATION, MULTIPLE FOLLOW UPS WERE MADE TO THE USER FACILITY IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED TO DATE. IN ADDITION, THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THEREFORE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THIS REPORT IS FOR 2 OF 2 DEVICES.

  Patient problems: Pain

  MAUDE report 9577485 ↗