Olympus WA22367ARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04042761066242), received between Apr 25, 2019 and Sep 14, 2026 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  The customer returned the Rigid endoscope working guide to the service center for a separate issue. During the device analysis, a broken distal end of the insertion section was found. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757253 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461550 ↗
• MalfunctionNov 21, 2025Output Problem; Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623884 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THERAPEUTIC GYNECOLOGIC SURGERY, MYOMECTOMY/TRANSURETHRAL RESECTION (TURI) UNDER SEDATION, THE RESECTOSCOPE CAUSED A FIRST TO SECOND DEGREE BURN TO THE PATIENT. THE BURN WAS REPORTED TO BE FROM THE GENITAL AREA (PUBIC AREA) TO THE BUTTOCKS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AS PLANNED. BURNS WERE DISCOVERED AFTER THE PROCEDURE. THE PATIENT WAS TREATED WITH A COLD WATER WASH AND TOPICAL OINTMENT; THE PATIENT WAS INITIALLY HOSPITALIZED FOR ORIGINAL PROCEDURE AND SCHEDULED FOR DISCHARGE THE FOLLOWING DAY, BUT THE DISCHARGE WAS POSTPONED AND HOSPITALIZATION WAS EXTENDED FOR THREE DAYS FOR OBSERVATION. THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO REPORTS OF MEDICAL INTERVENTION. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE NO PROBLEMS WITH THE PRODUCT, AND THE SITUATION WAS MONITORED. AS THE PROCEDURE WAS SWITCHED URGENTLY FROM NORMAL RESECTION TO TURI, THE PATIENT PLATE THAT WAS ATTACHED TO THE PATIENT WAS HEATED QUICKLY, LEADING TO POSSIBLE OVERHEATING.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 22391670 ↗
• MalfunctionJun 30, 2025Corroded; Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DIRT AND CORROSION OF THE TEFLON BLOCK. THE INSERTION TUBE AND BASE WERE RUSTED AND CANNOT BE SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358347 ↗
• MalfunctionMay 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116482 ↗
• MalfunctionMay 9, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT FOREIGN OBJECT WERE FOUND IN THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998894 ↗
• MalfunctionAug 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHILE USING THE WORKING ELEMENT WITH THE HIGH FREQUENCY UNIT, THE HIGH FREQUENCY UNIT EXHIBITED AN ERROR (INSTRUMENT CANNOT BE RECOGNIZED. UPON CHECKING THE PLASMA ELECTRIC CUTTING INTERFACE, IT WAS FOUND THAT THE INTERFACE WAS LOOSE AND SUSPECTED THAT POOR INTERFACE CONTACT HAD CAUSED THE MALFUNCTION. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC SURGERY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999860 ↗
• MalfunctionJul 17, 2024Output Problem; Output Problem

  IT WAS REPORTED THE WORKING ELEMENT DISPLAYED AN ERROR: E006(INSUFFICIENT CONDUCTIVITY). THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765130 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THEY HEARD A RUMOR THERE WAS A PERFORATION WHILE USING THE SUBJECT DEVICE DURING A GYNECOLOGY PROCEDURE.

  Patient problems: Perforation

  MAUDE report 19383770 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THEY HEARD A RUMOR THERE WAS A PERFORATION WHILE USING THE SUBJECT DEVICE DURING A GYNECOLOGY PROCEDURE.

  Patient problems: Perforation

  MAUDE report 19383688 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT AFTER TWENTY MINUTES INTO A TRANSURETHRAL RESECTION OF BLADDER (TURB) WHILE USING HF-RESECTION ELECTRODE, BUTTON, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS., ALONG WITH THE WORKING ELEMENT, THERE WAS NO RESECTION. THE DOCTOR INSTRUCTED THE NURSES TO CHECK THE SALINE SOLUTION AND IT WAS OK SO THEY ATTEMPTED AGAIN WITH SUCCESS. THERE WAS A UNEXPECTED LOUD SOUND FOLLOWED BY SMOKE. IT WAS STATED THAT THE PHYSICIAN WAS SCARED AND SWIFTLY PULLED THE INSTRUMENT FROM THE PATIENT RESULTING IN A BLADDER PERFORATION. THE PROCEDURE WAS TRANSITIONED TO AN OPEN PROCEDURE TO CLOSE THE PERFORATION. THE PATIENT WAS STATED TO BE STABLE AFTER THE OPEN SURGERY. THIS MDR REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): HF-RESECTION ELECTRODE, BUTTON, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS, MODEL WA22557C. (B)(6): WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE, MODEL WA22367A. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6), MODEL WA22367A.

  Patient problems: Internal Organ Perforation

  MAUDE report 18450953 ↗
• InjuryDec 15, 2023Failure to Conduct; Failure to Conduct

  THE CUSTOMER LATER CONFIRMED THE INCREASE IN INTRAOPERATIVE BLEEDING WAS MINOR AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THE ANESTHESIA TIME WAS EXTENDED BY 5 MINUTES. THE PROCEDURE WAS COMPLETED AND THE MALFUNCTION DID NOT AFFECT THE OUTCOME OF THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334956 ↗
• 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 SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375101 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AT THE END OF ENDOSCOPIC SURGERY FOR TRANSURETHRAL RESECTION FOR PROSTATIC ADENOMA (WEIGHING AROUND 50 GM) A VIOLENT INTRAVESICAL EXPLOSION OF A PROBABLE GASEOUS NATURE OCCURRED DURING THE USE OF CLOT CURRENT. THE PROCEDURE WAS IMMEDIATELY STOPPED, AND EXPLORATORY LAPAROTOMY WAS REQUIRED, REVEALED ENDO PERITONEAL LACERATION OF THE BLADDER. REPORTEDLY, THE BLADDER WAS COMPLETELY RUPTURED WITH BLEEDING AND INTRAVESICAL DISPLACEMENT OF INTESTINAL LOOPS WITH SOME ECCHYMOSIS. AS SUCH, COMPLEX EXPLORATORY SURGERY WAS PERFORMED TO REPAIR THE BLADDER. POST SURGERY, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER CARE. UPON FOLLOW-UP NO ADDITIONAL INFORMATION COULD BE RECEIVED REGARDING THE PATIENT'S CURRENT CONDITION. THERE WAS 6 DEVICES INVOLVED IN THIS EVENT REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: RELATED PATIENT IDENTIFIER# (B)(6), HF UNIT "ESG-400", MODEL- A42021A, SERIAL # (B)(6). RELATED PATIENT IDENTIFIER# (B)(6), OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE, MODEL- WA2T430A, SERIAL #(B)(6). RELATED PATIENT IDENTIFIER # (B)(6), TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE, MODEL- WA2T430A SERIAL # (B)(6). RELATED

  Patient problems: Ecchymosis; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Rupture; Unspecified Gastrointestinal Problem

  MAUDE report 17317791 ↗
• InjuryJan 11, 2022Output Problem; Activation Problem; Output Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC HYSTEROSCOPIC PROCEDURE IT WAS NOT POSSIBLE TO EFFECTIVELY CUT TISSUE AND STOP THE BLEEDING. ERROR E006 WAS ISSUED ON THE HF GENERATOR DUE TO POOR CONTACT BETWEEN ELECTRODE AND HYSTEROSCOPE BASE. THE SURGEON THEN USED A FORCEPS TO BEND AND FIRMLY CONNECT THE ELECTRODE TO THE BASE OF THE HYSTEROSCOPE. THE INTENDED PROCEDURE WAS THEN COMPLETED. HOWEVER, THE FAILURE LED TO A SIGNIFICANT PROLONGATION OF THE SURGERY TIME AND SIGNIFICANTLY INCREASED BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13222539 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE THE PATIENT WAS JERKING DUE TO ELECTRIC NERVE STIMULATION. CONSEQUENTLY THE ANESTHESIA WAS SWITCHED FROM SPINAL ANESTHESIA TO GENERAL ANESTHESIA. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12909464 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE PATIENT WAS JERKING DUE TO ELECTRIC NERVE STIMULATION. CONSEQUENTLY, SPINAL ANESTHESIA WAS USED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12909252 ↗
• InjuryMar 31, 2021Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TRANSCERVICAL RESECTION (TCR) PROCEDURE, THE PATIENT STARTED SHAKING AND SUFFERED AN EPISODE OF BRADYCARDIA WITH A HEART RATE DROP FROM 90 TO 30. WHEN THE SURGEON STOPPED ACTIVATION, THE PATIENT HEART RATE SLOWLY RETURNED TO NORMAL. UPON REACTIVATION, THE PATIENT LEG STARTED SHAKING AGAIN AND THE PATIENT WENT INTO BRADYCARDIA AGAIN. THE RESECTOSCOPE SET, HF CABLE, HF RESECTION LOOP ELECTRODE, AND HF GENERATOR WERE REPLACED BUT THE SAME INCIDENT HAPPENED AGAIN. THE INTENDED PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE HIGH DEPENDENCY WARD FOR HEART RATE MONITORING. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS.

  Patient problems: Bradycardia; Shaking/Tremors

  MAUDE report 11593996 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTICAL TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE BLADDER. THE INTENDED PROCEDURE WAS INITIALLY COMPLETED WITH THE SAME SET OF EQUIPMENT. THEN, THE NEXT DAY, A FOLLOW-UP LAPAROTOMY PROCEDURE WAS PERFORMED TO TREAT THE PERFORATION. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO REPORT OF A MALFUNCTION OF THE OLYMPUS MEDICAL DEVICES. FURTHERMORE, IT IS ASSUMED THAT A NERVE REFLEX IS CAUSAL FOR THE PERFORATION OF THE BLADDER BECAUSE NO NERVE BLOCK ANESTHESIA WAS PERFORMED.

  Patient problems: Internal Organ Perforation

  MAUDE report 10193639 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED HYSTEROSCOPY PROCEDURE UNDER GENERAL ANESTHESIA, IT WAS NOTICED THAT THE GAP BETWEEN THE SCOPE AND THE SHEATH WAS LEAKY AND THE UTERINE CAVITY COULD NOT BE SEEN. THEREFORE, THE OPERATION WAS CANCELLED AND A FOLLOW-UP HYSTEROSCOPY PROCEDURE HAD TO BE SCHEDULED TO COMPLETE THE INITIALLY INTENDED PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED, BUT THE PATIENT'S CONDITION IS REPORTEDLY GOOD AFTER THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8891967 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE BLADDER TUMOR (TURBT) PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE BLADDER. THE PERFORATION OCCURED WHEN, DURING HEMOSTASIS FOLLOWING THE BIOPSY, THE OPERATING SURGEON RETRACTED THE HF RESECTION ELECTRODE FROM THE MUCOUS MEMBRANE TO REMOVE TISSUE ADHESIONS FROM THE LOOP WIRE WHILE OUTPUT WAS STILL BEING EMITTED. NO FURTHER INFORMATION WAS PROVIDED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.

  Patient problems: Internal Organ Perforation

  MAUDE report 8548888 ↗