Olympus A22205CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 14042761036709), received between Dec 21, 2018 and Sep 5, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 8, 2023Open, Classified

   Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

   Z-2413-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE WAS BURNT AND CHARRED. THE EVENT OCCURRED DURING A TRANSURETHRAL RESECTION OF THE PROSTRATE. THE PROCEDURE WAS DELAYED FOR ABOUT 45 MINUTES. 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 22984233 ↗
• InjuryFeb 9, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE MALFUNCTION OCCURRED AT THE END OF THE PROCEDURE, AND THERE WAS A DELAY OF FIVE MINUTES OR MORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681713 ↗
• InjuryJun 28, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 30° BROKE OFF IN THE PATIENT AND WAS RETRIEVED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. IT WAS NOTED THAT THE MONOPOLAR ELECTRODE WAS USED WITH THE BIPOLAR ENERGY. A SHORT DELAY WAS NOTED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219780 ↗
• MalfunctionJun 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE HAD A DEFECTIVE LOOP OF THE ELECTRODE AND FAILED TO IGNITE PROPERLY DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ELECTRODE. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND THE WIRE AT THE DISTAL END WAS BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND AT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075259 ↗
• InjuryMay 7, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ENDOMETRIAL RESECTION OF FIBROID PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED BY CURETTAGE OF THE UTERUS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14315832 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE, TWO NEW (2) ELECTRODE LOOPS BROKE DURING THE CASE, FOR REALLY NO REASON. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO OTHER EQUIPMENT WAS REPLACED DURING THE PROCEDURE. THE REPORTED PROBLEM DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125005 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE, TWO NEW (2) ELECTRODE LOOPS BROKE DURING THE CASE, FOR REALLY NO REASON. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO OTHER EQUIPMENT WAS REPLACED DURING THE PROCEDURE. THE REPORTED PROBLEM DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124126 ↗
• MalfunctionSep 26, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  THE USER FACILITY REPORTED THAT THE DEVICE THAT BECAME FAULTY DURING A THERAPEUTIC ENDOMETRIAL RESECTION PROCEDURE. SALES REPRESENTATIVE REPORTED "VERY ROUTINE PROCEDURE UNTIL 3/4 THROUGH WHEN LOOP WAS OBSERVED TO HAVE BURNT AND DISINTEGRATED." THE SURGEON CHECKED WITH A SCOPE AND DID NOT FIND ANY DEVICE FRAGMENTS INSIDE THE PATIENT. THE SAME LOOP DEVICE WAS NOT USED TO COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED OR NEED FOR MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124368 ↗
• MalfunctionApr 29, 2019Break; Break

  INFORMATION WAS PROVIDED TO OLYMPUS WHICH STATED "THE LOOP DID NOT FALL INTO THE PATIENT, THE LOOP FAILED.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561385 ↗
• MalfunctionApr 26, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF A PROSTATE (TURP) PROCEDURE, THE LOOP AT THE DISTAL END OF THE DEVICE APPEARED TO BE THINNING OUT AND THE LOOP WOULD BREAK AT THE APEX. THE INTENDED PROCEDURE WAS COMPLETED UTILIZING A SECOND LIKE DEVICE FROM THE SAME LOT. THE REPORTED EVENT DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE REPORTED DEVICE WAS DISCARDED BY THE USER FACILITY FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556616 ↗
• MalfunctionDec 21, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF A PROSTATE (TURP) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE DEVICE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS THE INTENDED PROCEDURE WAS COMPLETED USING A SECOND DEVICE FROM THE SAME LOT. IN ADDITION, THERE WAS NO SPARKING OR ARCING OBSERVED DURING PROCEDURE; THERE WAS NO UNEXPECTED BLEEDING TO THE PATIENT; THERE WAS NO ISSUE WITHDRAWING THE DEVICE FROM THE PATIENT AND THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192390 ↗
• MalfunctionDec 21, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF A PROSTATE (TURP) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE DEVICE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS THE INTENDED PROCEDURE WAS COMPLETED USING A SECOND DEVICE FROM THE SAME LOT. IN ADDITION, THERE WAS NO SPARKING OR ARCING OBSERVED DURING PROCEDURE; THERE WAS NO UNEXPECTED BLEEDING TO THE PATIENT; THERE WAS NO ISSUE WITHDRAWING THE DEVICE FROM THE PATIENT AND THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192363 ↗