Olympus WA00014ARecalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 04042761076449), received between Jun 15, 2018 and Sep 14, 2026 — classified as 10 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Sparking” (56 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 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Sparking; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765833 ↗
• InjuryJul 8, 2026Intermittent Continuity; Disconnection

  IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR, ELECTRICITY DID NOT FLOW AS MUCH AS USUAL, AND AT SOME POINT, BEGAN TO FLOW AGAIN. WHEN ELECTRICITY STARTED FLOWING, NO OTHER OPERATIONS WERE BEING PERFORMED, ONLY TISSUE WAS BEING SCRAPED. THE PROCEDURE COMPLETED WITHOUT DELAY; THE IRRIGATION LIQUID WAS THOUGHT TO BE SALINE. UPON OBSERVING THE BLADDER INTERIOR POST-SURGERY, IT WAS FOUND THAT TISSUE IN THE AREA WHERE THE SHEATH WAS HAD BEEN BURNED WHITE. FOLLOW UP INFORMATION INDICATED THAT TREATMENT FOR THE BURN WAS PERFORMED AND ADDITIONALLY THAT THE MALFUNCTION WAS CAUSED BY DISCONNECTION OF THE CABLE. DESPITE MULTIPLE ATTEMPTS TO CLARIFY THE SEVERITY OF THE BURN, THE TREATMENT, AND THE PATIENT OUTCOME, NO DETAILS WERE OBTAINED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25754930 ↗
• MalfunctionJul 7, 2026Fracture; Arcing

  IT WAS REPORTED THE MEDICAL DEVICE CONNECTION CABLE'S BIPOLAR LEAD BEGAN TO SPARK DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE PROCEDURE WHILE THE DEVICE WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. FOLLOWING THE INCIDENT, THE LEAD BROKE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735290 ↗
• MalfunctionJul 7, 2026Sparking

  IT WAS REPORTED THE MEDICAL DEVICE CONNECTION CABLE HAD SPARKS AT THE CONNECTOR. THE ISSUE WAS FOUND DURING A THERAPEUTIC PLASMA TRANSURETHRAL RESECTION IN SALINE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735167 ↗
• MalfunctionJul 7, 2026Fracture; Sparking

  THE CUSTOMER REPORTED THAT, DURING A TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, SPARKS WERE OBSERVED FROM THE A CORD CONNECTED TO THE GENERATOR, AND THE CORD SUBSEQUENTLY BROKE. THE PROCEDURE WAS COMPLETED USING A SPARE DEVICE. FURTHER INVESTIGATION REVEALED THAT THE L-SHAPED CONNECTOR OF THE A CORD WAS BURNED AT THE ROOT PORTION. NO RECURRENCE WAS REPORTED WITH OTHER A CORDS OF THE SAME TYPE. THERE WERE NO REPORTS OF PATIENT INJURY, USER INJURY, OR OTHER ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735066 ↗
• MalfunctionJun 2, 2026Break; Sparking

  THE CUSTOMER REPORTED SPARKING AT THE BIPOLAR CABLES, AND THE CABLE BROKE OFF DURING PROCEDURE INVOLVING AN OLYMPUS ELECTRICAL ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359433 ↗
• MalfunctionMay 25, 2026Decoupling; Fire; Material Integrity Problem

  IT WAS REPORTED THAT THE CABLE OF THE REUSABLE ELECTRICAL ONLY MEDICAL DEVICE CONNECTION CABLE WAS NEARLY BROKEN NEAR THE FITTING CONNECTED TO THE RESECTOSCOPE. SUBSEQUENTLY, THE GENERATOR IMMEDIATELY DISPLAYED A WARNING INDICATING A CABLE DISRUPTION, AND A SMALL FLAME WAS OBSERVED COMING FROM THE CABLE. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270574 ↗
• MalfunctionMay 24, 2026Fracture; Sparking

  IT WAS REPORTED THAT, DURING OUTPUT, THE REUSABLE ELECTRICAL CONNECTION CABLE FOR THE MEDICAL DEVICE CAUSED A SPARK, AND THE CONNECTOR ON THE SCOPE SIDE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266523 ↗
• MalfunctionMay 15, 2026Break; Electrical /Electronic Property Problem; Sparking

  IT WAS REPORTED THE ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE EXHIBITED SPARKING AT THE BIPOLAR CABLES, AND THE CABLE BROKE OFF. THE ISSUE OCCURRED DURING UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193101 ↗
• MalfunctionFeb 10, 2026Melted

  IT WAS REPORTED THAT THE ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE HAD ONE OF THE TWO PRONGS ON THE SCOPE SIDE SPARK AND MELT. THE EVENT OCCURRED DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) THERAPEUTIC PROCEDURE, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304486 ↗
• MalfunctionFeb 2, 2026Break; Sparking

  IT WAS REPORTED THAT THE ELECTRICAL ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE DID SPARK AND HAD BROKEN INSULATION LAYER OF THE BIPOLAR CABLE. THE ISSUE OCCURRED DURING A THERAPEUTIC HYSTEROSCOPIC UTERINE MYOMA, FIBROID ELECTRIC RESECTION PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233130 ↗
• MalfunctionJan 29, 2026Break; Device Emits Odor; Sparking

  NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208893 ↗
• MalfunctionJan 28, 2026Break; Device Emits Odor; Sparking

  IT WAS REPORTED THAT THE ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE HAD SPARKED AND BURNED OUT. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200738 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED DURING SEDATION FOR A THERAPEUTIC ELECTROSURGICAL RESECTION PROCEDURE OF UTERINE FIBROIDS, THE SUBJECT DEVICE HAD A FRACTURED ELECTROSURGICAL CABLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842919 ↗
• MalfunctionDec 18, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840088 ↗
• MalfunctionNov 24, 2025Sparking; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631572 ↗
• MalfunctionSep 15, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052313 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978584 ↗
• MalfunctionAug 5, 2025Sparking; Sparking

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716087 ↗
• MalfunctionJul 3, 2025Fumes or Vapors; Fumes or Vapors

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396947 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HF-CABLE, BIPOLAR EXHIBITED A WIRE BREAKAGE HAD OCCURRED IN THE CABLE OF ONE OF THE TWO INSTRUMENT-SIDE CONNECTORS. THIS COULD LEAD TO A VOLTAGE FLASHOVER WHEN THE GENERATOR IS ACTIVATED, POTENTIALLY CAUSING SPARKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178219 ↗
• MalfunctionMay 5, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959184 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT THE GENERATOR HAD A BROKEN CORD. THE ISSUE WAS FOUND DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903351 ↗
• MalfunctionApr 22, 2025Overheating of Device; Overheating of Device

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879856 ↗
• MalfunctionJan 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A E006 ERROR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240632 ↗