Olympus WA22707SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 14042761085363), received between Nov 3, 2020 and Dec 17, 2025 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THE RESECTION ELECTRODE BIPOLAR LOOP FAILED DUE TO NON- CONDUCTIVITY. THE ISSUE WAS FOUND DURING AN UNSPECIFIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835115 ↗
• InjuryAug 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) THE SUBJECT DEVICE BROKE OFF INSIDE OF PATIENT. THE CUSTOMER REPORTED BEING UNSURE WHERE THE BROKEN PIECE IS LOCATED. THE PATIENT IS EXPECTED TO BE X-RAYED TO SEE IF IT CAN BE LOCATED. NO REPORTED HARM OR INJURY TO THE PATIENT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22793029 ↗
• MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636940 ↗
• InjuryNov 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC FIBROID RESECTION, THE DOCTOR WAS RESECTING A MASSIVE FIBROID WITH A VERY TIGHT CERVIX NEEDING TO CONSTANTLY DILATE EVERY TIME GOING IN AND OUT TO REMOVE THE CHIPS. AFTER APPROXIMATELY 20 MINUTES OF RESECTION, THE SUBJECT DEVICE BROKE INTRAOPERATIVELY INSIDE THE PATIENT. IT WAS CLARIFIED THAT THE DEVICE SPLIT, DID NOT FALL INTO ANYTHING, AND WAS RETRIEVED INTACT. THE DOCTOR THEN HAD TO DO A LAPAROSCOPY TO ENSURE THERE WAS NO PERFORATION. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY WITHOUT ANY REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641559 ↗
• MalfunctionOct 24, 2024Break; Break

  THE CUSTOMER REPORTED THAT AN OLYMPUS HF RESECTION ELECTRODE BROKE WHEN USED DURING A PROCEDURE. THE CUSTOMER CONFIRMED THAT NO FURTHER INFORMATION WAS AVAILABLE CONCERNING THIS EVENT. HOWEVER, THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522617 ↗
• MalfunctionOct 24, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER CONFIRMING AN EVENT DATE OF (B)(6) 2024. THE INITIAL REPORTER WENT ON TO NOTE THAT THE PROCEDURE HAD NOT YET COMMENCED AS THE LOOPS BROKE DURING PREPARATION. REPORTEDLY, THE INTENDED PROCEDURE WAS CONFIRMED COMPLETED WITHOUT PATIENT HARM OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522587 ↗
• InjuryFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT NO MEDICAL INTERVENTIONS WERE CONDUCTED TO LOCATE THE BROKEN DEVICE PIECE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18741834 ↗
• MalfunctionJan 20, 2024Melted; Melted

  THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FREQUENCY-RESECTION ELECTRODE "PLASMALOOP", HAD A BURNED DISTAL END. THE ISSUE WAS FOUND DURING A THERAPEUTIC, TRANSURETHRAL RESECTION IN SALINE SOLUTION PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548926 ↗
• InjuryDec 23, 2023Material Twisted/Bent; Material Twisted/Bent

  A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED A LOUD DING FROM THE HF UNIT "ESG-400" DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR. THE DOCTOR WAS USING A BIPOLAR LOOP AND THE ESG-400. WHEN THE DOCTOR HEARD THE LOUD NOISE FROM HF UNIT "ESG-400" THERE WAS A GLITCH AND THE DOCTOR PERFORATED THE BLADDER. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM FOR A CYSTOGRAM. THE INITIAL CASE WAS ABORTED AND THE EQUIPMENT WAS QUARANTINED. THIS MEDWATCH REQUIRES TWO REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): HF UNIT "ESG-400" .(B)(6): HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS. THIS MEDWATCH REPRESENTS (B)(6).

  Patient problems: Internal Organ Perforation

  MAUDE report 18389723 ↗
• InjuryDec 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED A LOUD DING FROM THE HF UNIT "ESG-400" DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR. THE DOCTOR WAS USING A BIPOLAR LOOP AND THE ESG-400. WHEN THE DOCTOR HEARD THE LOUD NOISE FROM HF UNIT "ESG-400" THERE WAS A GLITCH AND THE DOCTOR PERFORATED THE BLADDER. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM FOR A CYSTOGRAM. THE INITIAL CASE WAS ABORTED AND THE EQUIPMENT WAS QUARANTINED. THIS MEDWATCH REQUIRES TWO REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): HF UNIT "ESG-400". (B)(6): HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS. THIS MEDWATCH REPRESENTS (B)(6).

  Patient problems: Internal Organ Perforation

  MAUDE report 18389722 ↗
• MalfunctionDec 15, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS, AFTER THE STAFF OPENED THE BOX, THE HIGH FREQUENCY-RESECTION ELECTRODE "PLASMALOOP", HAD A BENT DISTAL END. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333204 ↗
• MalfunctionApr 12, 2023Material Twisted/Bent; Material Twisted/Bent

  THE THERAPEUTIC PROCEDURE (TRANSURETHRAL RESECTION OF BLADDER TUMOR) WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A MINOR DELAY OF A COUPLE OF MINUTES. NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729103 ↗
• MalfunctionApr 21, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  OLYMPUS RECEIVED A MEDWATCH# MW5107612 REPORT WITH A MALFUNCTION EVENT OF " PRODUCT WAS FOUND TO BE BROKEN WHILE USING DURING PROCEDURE. PRODUCT WAS BEING USED DURING CASE AND DR. SAID IT WAS "BURNT"/ BROKEN WHILE USING IN PATIENT. CASE CONTINUED WITH NEW PRODUCT". THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172068 ↗
• MalfunctionMar 15, 2022Break; Break

  THE OLYMPUS STONE MANAGEMENT SALES SPECIALIST WAS INFORMED BY THE NURSE AT THE USER FACILITY THAT THE HIGH FREQUENCY RESECTION ELECTRODE, PLASMA LOOP ¿BROKE¿ UPON INITIAL CLINICAL USE. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13766592 ↗
• MalfunctionDec 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE MIDDLE OF A TRANSURETHRAL RESECTION OF A BLADDER TUMOR PROCEDURE, THE LOOP OF THE HIGH FREQUENCY ELECTRODE CAME OFF AND FELL INSIDE THE PATIENT. THE BROKEN LOOP FRAGMENT WAS RETRIEVED FROM THE PATIENT AS THE PHYSICIAN WAS ABLE TO FLUSH THE TIP SUCCESSFULLY. THE NURSE AT THE USER FACILITY FURTHER REPORTED THE PHYSICIAN WAS ABLE TO COMPLETED THE INTENDED PROCEDURE USING A SIMILAR DEVICE WITHOUT DELAY. NO OTHER DEVICES WERE REPLACED DURING THE CASE. BOTH THE ENDOSCOPE AND THE PLASMA LOOP WERE INSPECTED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11035977 ↗
• MalfunctionNov 3, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED THAT A LOOP BROKE ON AN ELECTRODE DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778184 ↗