Olympus WA22703SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 14042761085332), received between Dec 27, 2018 and Mar 18, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC BLADDER TUMOR RESECTION PROCEDURE PERFORMED UNDER SEDATION, THE SURGEON EXPERIENCED OBTURATOR NERVE REFLEX WHILE USING THE OLYMPUS BIPOLAR SYSTEM WITH A DEFECTIVE PLASMA LOOP ELECTRODE, RESULTING IN A BLADDER PERFORATION. THE SURGEON CAUTERIZED THE BLEEDER, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN OLYMPUS BACKUP DEVICE, WITH A DELAY OF LESS THAN 30 MINUTES. ADDITIONAL FOLLOW-UP REGARDING THE PROCEDURE DETAILS AND THE PATIENT¿S OUTCOME WAS ATTEMPTED; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 24634635 ↗
• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT DURING HYSTEROSCOPY WITH ENDOMETRIAL RADIOFREQUENCY ABLATION, THE ELECTRODE LOOP GOT CAUGHT ON A FIBROID AND BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS NOT RETRIEVED. A CT SCAN CONFIRMED THE LOOSE PIECE. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND COMPLETED USING ANOTHER NEW ELECTRODE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23824552 ↗
• MalfunctionDec 16, 2025Melted; Melted

  IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD A MELTED PLASMA LOOP. THIS MALFUNCTION OCCURRED DURING A UROLOGY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821694 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280049 ↗
• MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036529 ↗
• MalfunctionOct 25, 2023Break; Break

  THE CUSTOMER REPORTED THAT PART OF THE LOOP PORTION OF THE HF-RESECTION ELECTRODE "PLASMA LOOP" BROKE. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18001536 ↗
• MalfunctionAug 31, 2023Break; Melted; Break; Melted

  THE CUSTOMER REPORTED THAT THE ELECTRODE LOOP DISTAL END MELTED DURING A TRANSURETHRAL RESECTION OF BLADDER NECK PROCEDURE. THE PROCEDURE WAS DELAYED 5 MINUTES AND WAS COMPLETED WITH A SIMILAR DEVICE. A 5 MINUTE DELAY IS NOT SIGNIFICANT. THE PATIENT CONDITION WAS NOT AFFECTED BY THE FAILURE AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666422 ↗
• MalfunctionJul 27, 2021Break; Break

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) THE LOOPS FROM TWO HF-ELECTRODES BROKE OFF INSIDE THE PATIENT. IT WAS REPORTED THAT LOOPS WERE RETRIEVED WITH AN UNKNOWN DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH A THIRD LOOP WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY REPORTED. IN ADDITION, ON JULY 09, 2021, OLYMPUS RECEIVED A VOLUNTARY MEDWATCH (MW5101862) PERTAINING TO THE EVENTS STATED IN THIS REPORT AND NO ADDITIONAL INFORMATION PROVIDED. THIS MFR. REPORT ADDRESSES LOOPS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232054 ↗
• MalfunctionNov 15, 2019Output Problem; Output Problem

  THE MANUFACTURER WAS INFORMED THAT AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE CUSTOMER WAS HAVING A HARD TIME FIRING THE LOOP AS THE LOOP WAS SPUTTERING AND AT TIMES UNRESPONSIVE. A SECOND ELECTRODE LOOP WAS USED BUT THE SAME PROBLEM PERSISTED. THERE WAS NO BREAKAGE OR SPARKING/ARCING TO THE LOOPS REPORTED. THEN TRIED TO REPLACE THE GENERATOR BUT THE SAME ISSUE OCCURRED. THE GENERATOR SETTINGS WERE SET TO DEFAULT 200WATTS (CUT)-120WATTS (COAG). THE USER REPORTED THERE WAS NO ERRORS OBSERVED AND THAT THE GENERATOR DID NOT MALFUNCTION AS THE USER DETERMINED THE PROBLEM WAS WITH THE LOOP AS ONCE THE USER OPENED A DIFFERENT (MEDIUM) LOOP IT WORKED AND THE PROCEDURE WAS COMPLETED. THERE WAS A 30-40 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO SERIOUS INJURY OR DEATH REPORTED. THE ELECTRODE AND CONNECTIONS TO THE WORKING ELEMENT WERE INSPECTED PRIOR TO USE, THERE WERE NO ANOMALIES NOTED. THIS IS FOR 2 OF 2 REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9330310 ↗
• MalfunctionNov 13, 2019Output Problem; Output Problem

  THE MANUFACTURER WAS INFORMED THAT AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE CUSTOMER WAS HAVING A HARD TIME FIRING THE LOOP AS THE LOOP WAS SPUTTERING AND AT TIMES UNRESPONSIVE. A SECOND ELECTRODE LOOP WAS USED BUT THE SAME PROBLEM PERSISTED. THERE WAS NO BREAKAGE OR SPARKING/ARCING TO THE LOOPS REPORTED. THEN TRIED TO REPLACE THE GENERATOR BUT THE SAME ISSUE OCCURRED. THE GENERATOR SETTINGS WERE SET TO DEFAULT 200WATTS (CUT)-120WATTS (COAG). THE USER REPORTED THERE WAS NO ERRORS OBSERVED AND THAT THE GENERATOR DID NOT MALFUNCTION AS THE USER DETERMINED THE PROBLEM WAS WITH THE LOOP AS ONCE THE USER OPENED A DIFFERENT (MEDIUM) LOOP IT WORKED AND THE PROCEDURE WAS COMPLETED. THERE WAS A 30-40 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO SERIOUS INJURY OR DEATH REPORTED. THE ELECTRODE AND CONNECTIONS TO THE WORKING ELEMENT WERE INSPECTED PRIOR TO USE, THERE WERE NO ANOMALIES NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317413 ↗
• MalfunctionDec 27, 2018Break; Break

  OLYMPUS WAS INFORMED VIA MEDWATCH REPORT (B)(4) THAT DURING A CYSTOSCOPY WITH TRANSURETHRAL RESECTION OF PROSTATE, THE LOOP OF THE DEVICE BROKE IN THE MIDDLE AND A FRAGMENT FELL INTO THE BLADDER. THE FRAGMENT WAS WASHED OUT OF THE PATIENT BY FLUSHING THE BLADDER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8201480 ↗