Olympus A22201DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14042761036655), received between Nov 24, 2020 and Sep 11, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT DURING THE TRANSURETHRAL RESECTION (TCR) THERAPEUTIC PROCEDURE THE HF-RESECTION ELECTRODE HAD DAMAGED ELECTRODES AND NONE OF THE ELECTRODES FELL OUT OF THE BODY. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20187611 ↗
• MalfunctionSep 9, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, THE SUBJECT DEVICE¿S ELECTRODE WAS DAMAGED, DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE. THE PROCEDURE WAS COMPLETED. AND THERE WERE NO REPORTS OF DELAY. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176935 ↗
• MalfunctionOct 2, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE LOOP WAS DAMAGED DURING RESECTION. THE DEVICE WAS REPLACED BEFORE IT RUPTURED. THE REPORTED ISSUE WAS OBSERVED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857160 ↗
• MalfunctionAug 16, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE LOOP HAD FAILED WITH THE WIRE , OPEN DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555219 ↗
• InjuryMar 30, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING TWO DIFFERENT THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR, THIS RESECTION ELECTRODE LOOPS BROKE. THE FIRST CASE, THE LOOP BROKE COMPLETELY OFF. THE SECOND CASE, THE LOOP BROKE IN HALF. BOTH PROCEDURES WERE PROLONGED DUE TO THE NEED TO OBTAIN REPLACEMENT LOOPS AND VERIFY THE BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THE FIRST CASE WAS 1 3/4 HOURS AND THE SECOND CASE 2 HOURS. IN BOTH OCCURRENCES, THE LOOP WAS REMOVED SUCCESSFULLY AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING A SIMILAR DEVICE. X-RAYS WERE OBTAINED TO CONFIRM BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) - 1ST CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. (B)(6) - 2ND CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653072 ↗
• InjuryMar 30, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING TWO DIFFERENT THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR, THIS RESECTION ELECTRODE LOOPS BROKE. THE FIRST CASE, THE LOOP BROKE COMPLETELY OFF. THE SECOND CASE, THE LOOP BROKE IN HALF. BOTH PROCEDURES WERE PROLONGED DUE TO THE NEED TO OBTAIN REPLACEMENT LOOPS AND VERIFY THE BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THE FIRST CASE WAS 1 3/4 HOURS AND THE SECOND CASE 2 HOURS. IN BOTH OCCURRENCES, THE LOOP WAS REMOVED SUCCESSFULLY AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING A SIMILAR DEVICE. X-RAYS WERE OBTAINED TO CONFIRM BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6)- 1ST CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. (B)(6)- 2ND CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653051 ↗
• MalfunctionNov 24, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF-RESECTION ELECTRODE DETACHED. IT IS UNKNOWN WHETHER THE DETACHED PARTS REMAINED INSIDE THE PATIENT¿S BODY SINCE THEY COULD NOT BE FOUND WITHIN AN X-RAY EXAMINATION OF THE PATIENT OR WHEN SEARCHING THE FACILITY. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10895237 ↗