Olympus WA22366ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04042761066235), received between Apr 16, 2020 and Sep 2, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Overheating of Device

  Patient problems: Urethral Stenosis/Stricture; Urinary Incontinence

  MAUDE report 50574021 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE PATIENT FELT LIGHT CURRENT LEAKAGE FROM THE WORKING ELEMENT WITHOUT ANY INJURY. IT WAS LATER REPORTED THAT WITHIN AROUND 2 MONTHS AFTER THE PROCEDURE USING THE SUBJECT DEVICE, THE PATIENT DEVELOPED URETHRAL STRICTURES. THE STRICTURES WERE LATER TREATED BY THE DOCTOR AND THE PATIENT IS REPORTEDLY FINE AFTER THE TREATMENT. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 20248901 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, WHILE USING THE RESECTOSCOPE AN INTRAVESICAL OXYHYDROGEN EXPLOSION OCCURRED IN WHICH THE PATIENT'S BLADDER WAS PERFORATED SEVERAL TIMES. THE PATIENT HAD TO UNDERGO EMERGENCY SURGERY, THE BLADDER WAS RECONSTRUCTED, AND THE BLADDER FUNCTION WAS RESTORED. THE OPERATING TIME WAS EXTENDED BY APPROXIMATELY 3 HOURS WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Internal Organ Perforation

  MAUDE report 20208791 ↗
• InjuryJun 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING A BLADDER RESECTION USING BIPOLAR ENERGY. THE BLADDER PERFORATION OCCURRED WHEN THE SURGEON APPROACHED THE PATIENT¿S OBTURATOR NERVE. THE PATIENT WAS NOT INJURED BY ELECTRIC CURRENT AND/OR SHOCK. THE GENERATOR DID NOT DISPLAY AN ERROR MESSAGE. THE GENERATOR WAS PROGRAMMED TO A ¿CLASSIC¿ BIPOLAR SETTING RECOMMENDED BY OLYMPUS. DUE TO THE BLADDER PERFORATION, AN EMERGENCY LAPAROTOMY WAS PERFORMED. THIS RESULTED IN A 1-HOUR PROCEDURAL DELAY. THE SURGEON REPORTED THE INCIDENT TO THE HOSPITAL¿S BIOMEDICAL TEAM.

  Patient problems: Internal Organ Perforation

  MAUDE report 19538135 ↗
• MalfunctionApr 8, 2024Output Problem; Output Problem

  IT WAS REPORTED, THAT THE ELECTROSURGICAL UNIT HAD AN E006 ERROR. THE ISSUE WAS FOUND DURING THE TRANSURETHRAL RESECTION 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 19066740 ↗
• MalfunctionNov 29, 2023Sparking; Sparking

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-CABLE, BIPOLAR WHEN USED TO OUTPUT HIGH FREQUENCY SIGNALS, SPARKS WERE GENERATED, AND A HOLE WAS CREATED IN THE DOCTOR¿S GLOVE. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229085 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS EXPERIENCED CONSECUTIVE URETHRAL STRICTURES AFTER TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURES IN WHICH THE WORKING ELEMENT (WA22366A) AND 24FR RESECTION SHEATH (A22041A) WERE USED IN COMBINATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND NO ADDITIONAL MEDICAL TREATMENT OR SURGICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT EITHER THE HANDLE OR THE SHEATH WAS THE CAUSE. RELATED PATIENT IDENTIFIERS: (B)(6) WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE (WA22366A / 147W0080). (B)(6) WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE (WA22366A / 147W0080). (B)(6) RESECTION SHEATH, 24 FR. (A22041A / 147W0083). (B)(6) RESECTION SHEATH, 24 FR. (A22041A / 147W0083). THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 18219513 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD FOR KH 11/28 THE PATIENTS EXPERIENCED CONSECUTIVE URETHRAL STRICTURES AFTER TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURES IN WHICH THE WORKING ELEMENT (WA22366A) AND 24FR RESECTION SHEATH (A22041A) WERE USED IN COMBINATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND NO ADDITIONAL MEDICAL TREATMENT OR SURGICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT EITHER THE HANDLE OR THE SHEATH WAS THE CAUSE. RELATED PATIENT IDENTIFIERS: (B)(6) WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE (WA22366A / 147W0080). (B)(6) WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE (WA22366A / 147W0080). (B)(6) RESECTION SHEATH, 24 FR. (A22041A / 147W0083). (B)(6) RESECTION SHEATH, 24 FR. (A22041A / 147W0083). THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 18219411 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A PLANNED LASER PROSTATE RESECTION ON (B)(6) 2023, A NON-OLYMPUS LASER WAS BEING USED INITIALLY BUT DUE TO SOME TECHNICAL ISSUE WITH THE LASER EQUIPMENT, THE DOCTOR USED THE OLYMPUS RESECTION SET WITH A NON-OLYMPUS KNIFE. AFTER USING THE DEVICE FOR NEARLY 20 TO 25 MINUTES, THE DOCTOR HAD SHIFTED TO A DIFFERENT NON-OLYMPUS LASER AND COMPLETED THE PROCEDURE WITH NO COMPLICATIONS AT THAT POINT. AT A LATER DATE ON (B)(6) 2023, THE CATHETER WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS OKAY AT THAT TIME. ON (B)(6) 2023, THE PATIENT HAD A FOLLOW-UP VISIT AND PER THE DOCTOR THE PATIENT WAS FINE. ON (B)(6) 2023, THE PATIENT NOTICED A "URINE LEAK" AND NOTIFIED A DOCTOR. ON (B)(6) 2023, THE OPERATING DOCTOR BECAME AWARE AND RECEIVED PICTURES THAT THE PATIENT PROVIDED. THE DOCTOR ADVISED FOR A NEEDED URETHRAL RECONSTRUCTION AND NO OTHER COMPLICATIONS. THIS EVENT REQUIRES 6 REPORTS. RELATED PATIENT IDENTIFIERS: (B)(6) / MODEL: WB91051W SN: (B)(6) / MODEL:WA22366A SN: (B)(6) / MODEL:A22040A SN: (B)(6) / MODEL: A22026A SN: (B)(6) / MODEL: WA22355C SN: UNKNOWN (B)(6) / MODEL: WA00014A SN: (B)(6) THIS MEDWATCH IS FOR PATI

  Patient problems: Urinary Incontinence

  MAUDE report 18040356 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AN ELECTRICAL FAILURE OCCURRED AND NO IMAGE DURING THE HYSTEROSCOPIC MYOMECTOMY AND THE SAME PROBLEM OCCURRED AFTER REPLACING ALL THE COMBINED DEVICES CAUSING A 30-MINUTE DELAY IN SURGERY AND 30 MINUTES EXTENDED ANESTHESIA TIME. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS COMPLETED USING OTHER UROLOGICAL PRODUCTS. THE EVENT DID NOT AFFECT THE DIAGNOSTIC OR TREATMENT OUTCOME. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 12 REPORTS. RELATED PATIENT IDENTIFIERS FOR THE FIRST COMBINATION OF DEVICES USED ARE AS FOLLOWS: (B)(6) (WA00014A / HF-CABLE, BIPOLAR) (B)(6) (WA00014A / HF-CABLE, BIPOLAR) (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS) (B)(6) (A42021A / OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE) (B)(6) (WA22366A /WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE) (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400) RELATED PATIENT IDENTIFIERS FOR THE SECOND COMBINATION OF DEVICES USED: (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400) (B)(6) (WA22366A / WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE) (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371354 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT A SERIES OF PATIENTS DEVELOPED URETHRAL STRICTURES FOLLOWING TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURES USING A COMBINATION OF THIS RIGID ENDOSCOPE WORKING GUIDE AND RESECTION SHEATH. TWO PATIENTS HAVE BEEN CONFIRMED SO FAR, BUT THERE MAY BE MORE. THERE WAS AN OPINION FROM THE PHYSICIAN THAT THE CAUSE WAS EITHER THE HANDLE OR THE SHEATH. THE DEVICES WERE INSPECTED PRIOR TO USE. NO ERRORS DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6)- PATIENT 1 RIGID ENDOSCOPE WORKING GUIDE. (B)(6)- PATIENT 1 RESECTION SHEATH. (B)(6)- PATIENT 2 RIGID ENDOSCOPE WORKING GUIDE (B)(6)- PATIENT 2 RESECTION SHEATH THIS REPORT IS FOR (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 17093434 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT A SERIES OF PATIENTS DEVELOPED URETHRAL STRICTURES FOLLOWING TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURES USING A COMBINATION OF THIS RIGID ENDOSCOPE WORKING GUIDE AND RESECTION SHEATH. TWO PATIENTS HAVE BEEN CONFIRMED SO FAR, BUT THERE MAY BE MORE. THERE WAS AN OPINION FROM THE PHYSICIAN THAT THE CAUSE WAS EITHER THE HANDLE OR THE SHEATH. THE DEVICES WERE INSPECTED PRIOR TO USE. NO ERRORS DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) - PATIENT 1 RIGID ENDOSCOPE WORKING GUIDE (B)(6) - PATIENT 1 RESECTION SHEATH (B)(6)- PATIENT 2 RIGID ENDOSCOPE WORKING GUIDE (B)(6) - PATIENT 2 RESECTION SHEATH THIS REPORT IS FOR (B)(6).

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 17093394 ↗
• InjuryMar 1, 2023Output Problem; Output Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED RESECTION PROCEDURE, A BIPOLAR RESECTION KIT WAS USED, AND IT WAS REPORTEDLY ¿UNSATISFACTORY AND INEFFICIENT¿. THUS, THE INTENDED PROCEDURE COULD NOT BE COMPLETED, AND A FOLLOW-UP PROCEDURE IS REQUIRED. HOWEVER, SINCE THE HOSPITAL WAS UNABLE TO IDENTIFY THE AFFECTED PRODUCT, IT SENT IN FOUR POSSIBLE WORKING ELEMENTS: (B)(4) WITH LOT NUMBERS 114W, 166W, 14YW AND 20901-0009. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16458595 ↗
• InjuryJun 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE THE WORKING ELEMENT STOPPED WORKING IN THE MIDDLE OF SURGERY. THE SURGEON TRIED TO CHANGE THE DIATHERMY MACHINE AND SWAPPED THE PEDALS BUT IT STILL DID NOT WORKED. THE INTENDED PROCEDURE WAS ABANDONED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14798033 ↗
• InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED RESECTION PROCEDURE THE PATIENT SUSTAINED A NECROSIS IN THE URETHRA. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS.

  Patient problems: Necrosis

  MAUDE report 9968161 ↗