Olympus A22201CRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 14042761036648), received between May 1, 2017 and Dec 15, 2025 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810696 ↗
• InjuryMay 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RESECTION ELECTRODE BROKE INSIDE THE PATIENT'S UTERUS DURING AN UNKNOWN THERAPEUTIC PROCEDURE. A SEARCH WAS CONDUCTED FOR THE MISSING END, WHICH WAS FOUND INSIDE THE PATIENT'S UTERUS. THERE WERE NO REPORTS OF PATIENT HARM. FURTHER FOLLOW-UP IS CONDUCTED TO OBTAIN ADDITIONAL INFORMATION AND IS CURRENTLY PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971664 ↗
• InjuryDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT PREVIOUSLY UNDERWENT A HYSTEROSCOPIC RESECTION OF THE LESION; ENDOMETRIAL POLYP AND SUBMUCOSAL MYOMA RESECTION ON (B)(6) 2022 WHEREIN THE SUBJECT DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. APPROXIMATELY TWO YEARS LATER, AT THE PATIENT'S REQUEST, THE USER FACILITY ASKED FOR DETAILED INFORMATION ON THE MATERIALS FROM WHICH THE SUBJECT DEVICE WAS MADE AS THE PATIENT HAD IMAGING EXAMINATION THAT REVEALED A METAL ELEMENT IN THE UTERUS. THE USER FACILITY INDICATED THAT THEY JUST WANTED TO EXCLUDE OR CONFIRM THAT THIS ELEMENT FOUND IN THE PATIENT IS PART OF THE SUBJECT DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. ADDITIONAL INFORMATION ON PATIENT OUTCOME AND FURTHER PATIENT IMPACT WERE REQUESTED BUT NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20854407 ↗
• InjuryJul 24, 2024Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT'S BLADDER. THE LOOP WAS FOUND AS SOON AS IT HAPPENED AND THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823747 ↗
• MalfunctionJun 7, 2024Sparking; Material Twisted/Bent; Sparking; Material Twisted/Bent

  IT WAS REPORTED THE HF (HIGH FREQUENCY)-RESECTION ELECTRODE WHEN USED WITH THE WORKING ELEMENT NO LONGER WORKED IN BIPOLAR OR MONOPOLAR MODE. THE ISSUE WAS REALIZED WHILE ALREADY IN THE PATIENT¿S BLADDER. THE CONNECTIONS HAD BEEN CHECKED AND CHANGED TWICE BUT NOTHING HELPED. AFTER A WHILE, A LOUD NOISE WAS HEARD, AND THE BLACK PART USED TO REMOVE THE HANDLE JUMPED WITH A SMALL JET OF SPARK. THE LOOP SEEMED TO HAVE BEEN CRUSHED AND THE HANDLE TO HAVE FAILED. THE DEVICE DID NOT FALL OFF INSIDE THE PATIENT AND THERE WAS NO MEDICAL INTERVENTION NEEDED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488580 ↗
• MalfunctionOct 4, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE, 12 PCS. ELECTRODE LOOPS BROKE DURING A THERAPEUTIC RESECTION. IT HAD BEEN BEING USED FOR 45-60 MINUTES WHEN THIS OCCURRED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867531 ↗
• MalfunctionSep 29, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE ELECTRODE LOOPS ON HER OLYMPUS HF RESECTION SINGLE-USE ELECTRODE LOOP BROKE WHILE IN USE DURING A PROCEDURE. ACCORDING TO THE INITIAL REPORTER, SHE HAD TWO BREAK DURING USE. REPORTEDLY, THIS UNIT WAS ONLY USED FOR 45-60 MINUTES, WITH A CAUTERY SETTING OF 160CUT AND 70SPRAY. THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT ANY PATIENT HARM. THIS RECORD IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844464 ↗
• InjurySep 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT PART OF THE HF-RESECTION ELECTRODE BROKE OFF INSIDE THE PATIENT AND THE DOCTOR WAS UNABLE TO FIND IT, BUT IT SHOWED UP ON THE X-RAY IN THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17738087 ↗
• InjurySep 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT PART OF THE HF-RESECTION ELECTRODE BROKE OFF INSIDE THE PATIENT AND THE DOCTOR WAS UNABLE TO FIND IT, BUT IT SHOWED UP ON THE X-RAY IN THE PATIENT. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17737923 ↗
• InjurySep 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC UROLOGY PROCEDURE USING THE HF RESECTION ELECTRODE, THE LOOP BROKE OFF AND FELL INTO THE PATIENT AND WAS UNABLE TO BE LOCATED. IT REMAINED IN THE PATIENT. THE PROCEDURE WAS PROLONGED "DRAMATICALLY." IT WAS REPORTED THAT THE CONDITION OF THE PATIENT AND THE DIAGNOSTIC OUTCOME WAS IMPACTED BY THE FAILURE, BUT IT WAS NOT SPECIFIED HOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. REPORTEDLY, A DIAGNOSTIC INTERVENTION WILL BE UNDERTAKEN TO LOCATE THE MISSING DEVICE PIECE LEFT IN THE PATIENT¿S BODY (MRI/X-RAY). ADDITIONAL FOLLOW UP HAS BEEN CONDUCTED REGARDING THE BROKEN PIECE LEFT IN THE PATIENT AND THE PATIENT OUTCOME; HOWEVER, THE INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17702750 ↗
• InjurySep 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC UROLOGY PROCEDURE USING THE HF RESECTION ELECTRODE, THE LOOP BROKE OFF AND FELL INTO THE PATIENT AND WAS UNABLE TO BE LOCATED. IT REMAINED IN THE PATIENT. THE PROCEDURE WAS PROLONGED "DRAMATICALLY." IT WAS REPORTED THAT THE CONDITION OF THE PATIENT AND THE DIAGNOSTIC OUTCOME WAS IMPACTED BY THE FAILURE, BUT IT WAS NOT SPECIFIED HOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. REPORTEDLY, A DIAGNOSTIC INTERVENTION WILL BE UNDERTAKEN TO LOCATE THE MISSING DEVICE PIECE LEFT IN THE PATIENT¿S BODY (MRI/X-RAY). ADDITIONAL FOLLOW UP HAS BEEN CONDUCTED REGARDING THE BROKEN PIECE LEFT IN THE PATIENT AND THE PATIENT OUTCOME; HOWEVER, THE INFORMATION WAS NOT AVAILABLE AT THE TIME OF REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17702520 ↗
• MalfunctionAug 30, 2023Sparking; Sparking

  THE CUSTOMER REPORTED THAT A HF-RESECTION ELECTRODE, LOOP, DID NOT WORK INITIALLY, THEN SPARKED DURING A PROCEDURE. THE EVENT OCCURRED DURING THE PROCEDURE AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY, OR NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650630 ↗
• InjuryAug 29, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOMETRIAL ABLATION USING ELECTRODE RESECTOSCOPE CUTTING LOOP 24FR 12 DEGREE, THE LOOP RESECTION END BROKE OFF OF THE ELECTRODE INSIDE THE PATIENT'S UTERUS. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES AND THE ELECTRODE IMMEDIATELY WITH A PAIR OF FORCEPS. IT WAS CONFIRMED THAT ALL PIECES WERE REMOVED AND CONFIRMED ALL DEVICE PIECES REMOVED, THROUGH THE SCOPE ALREADY IN USE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642311 ↗
• MalfunctionAug 14, 2023Melted; Melted

  THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. THE INFORMATION REGARDING THE DEVICE THAT WAS USED TO COMPLETE THE PROCEDURE IS UNKNOWN. THE PROCEDURE WAS NOT PROLONGED. THE PATIENT'S ANESTHESIA OR SEDATION WAS NOT EXTENDED. THE PROCEDURE DID NOT NEED TO BE CANCELLED OR POSTPONED. THE PROCEDURE DID NOT NEED TO BE CANCELLED OR POSTPONED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. IT IS NOT AVAILABLE AS TO WHETHER ANY OTHER SUBJECT DEVICES CONNECTED WHEN THE FAILURE OCCURRED. THE PATIENT DEMOGRAPHICS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542268 ↗
• InjuryJun 27, 2023Material Integrity Problem; Material Integrity Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING CYSTOSCOPY WITH TRANSURETHRAL RESECTION OF A BLADDER TUMOR, WHILE USING THE "HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE" TO DISSECT TISSUE, THE LOOP OF THE ELECTRODE "VAPORIZED" IN THE BLADDER. THE DEVICE WAS REMOVED FROM THE PATIENT'S BLADDER AND REPLACED WITH A NEW LOOP. IT WAS UNKNOWN HOW THE DEVICE WAS RETRIEVED. NO DELAY'S OR INJURIES OCCURRED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213673 ↗
• InjuryJan 5, 2023Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FRAGMENTS FELL INTO THE PATIENT. ONE TINY FRAGMENT REMAINED INSIDE THE PATIENT SINCE THE SURGEON WAS UNABLE TO RETRIEVE IT. THE SURGEON BELIEVES THAT THIS WILL PASS IN URINE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT A PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16100650 ↗
• InjuryNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS RECEIVED A VOLUNTARY MW REPORTING AN UNSPECIFIED PROCEDURE DURING WHICH A RESECTION ELECTRODE LOOP 24F BROKE INSIDE THE PATIENT. OLYMPUS IS UNABLE TO REQUEST ADDITIONAL DETAILS REGARDING THE PATIENT OR REPORTED EVENT, THE REPORTER REQUESTED IDENTITY AND CONTACT INFORMATION REMAIN CONFIDENTIAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15739610 ↗
• InjuryNov 4, 2022Break

  OLYMPUS RECEIVED A VOLUNTARY MW REPORTING AN UNSPECIFIED PROCEDURE DURING WHICH A RESECTION ELECTRODE LOOP 24F BROKE INSIDE THE PATIENT. OLYMPUS IS UNABLE TO REQUEST ADDITIONAL DETAILS REGARDING THE PATIENT OR REPORTED EVENT, THE REPORTER REQUESTED IDENTITY AND CONTACT INFORMATION REMAIN CONFIDENTIAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15739443 ↗
• MalfunctionMay 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER CARE REPRESENTATIVE WAS INFORMED BY THE USER FACILITY THAT THE CUSTOMER SINGLE USE HIGH FREQUENCY RESECTION ELECTRODE, LOOP FAILED DURING USE. THE ¿LOOP BROKE WHILE IN USE. NO PIECES WERE LEFT IN THE PATIENT.¿ NO DEATH OR SERIOUS INJURY WAS REPORTED TO OLYMPUS. THE ELECTRODE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366220 ↗
• MalfunctionApr 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC TURP ( TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE , AFTER TWO MINUTES OF NORMAL USE, THE LOOP BROKE IN HALF. THE ELECTRODE AND CORD WERE INSPECTED FOR DAMAGE PRIOR TO USE. THE LOOP DID NOT CONTACT ANY HARD OR METAL OBJECT DURING USE. ACCORDING TO THE REPORTER, THE LOOP DISINTEGRATED INSIDE THE PATIENT AND THE FRAGMENTS WERE WASHED OUT BY THE IRRIGATION FLUID, THE BROKEN PIECE DISINCARNATED INSIDE THE PATIENT. A SECOND LOOP OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE TIME WAS EXTENDED BY 20 MINUTES. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM, INJURY OR INFECTION REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116105 ↗
• MalfunctionAug 11, 2021Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE RESECTOSCOPE LOOP BROKE INTRAOPERATIVELY DURING USE. THE CUSTOMER REPORTED NO ADVERSE EVENT OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED OF THE CUSTOMER. HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE BROKEN LOOP FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309241 ↗
• MalfunctionMar 23, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE AND FRAGMENTS FELL INTO THE PATIENT. IT IS UNKNOWN WHETHER OR NOT FRAGMENTS MAY HAVE REMAINED INSIDE THE PATIENT. AN X-RAY EXAMINATION WAS TO BE PERFORMED TO CONFIRM THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT, THE RESULTS OF WHICH HAVE NOT BEEN PROVIDED. HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11552490 ↗
• MalfunctionFeb 10, 2021Break; Break

  OLYMPUS RECEIVED AN INITIAL REPORT (AHS MDIP # 8075) FROM ALBERTA HEALTH SERVICE THAT STATES DURING A BLADDER RESECTION PROCEDURE, APPROXIMATELY 3MM OF LOOP BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE SURGEON WAS RESECTING A BLADDER TUMOR WHEN THE PHENOMENON OCCURRED. ACCORDING TO THE REPORT, THE SURGEON IRRIGATED THE PATIENT¿S BLADDER WITH STERILE WATER TO FLUSH OUT THE CAUTERY LOOP PIECE. HOWEVER, THE LOOP PIECE WAS TOO SMALL TO CONFIRM IF IT FLUSHED OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11306830 ↗
• MalfunctionMay 23, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE, WHILE THE SURGEON WAS RESECTING TISSUE IT WAS NOTED THAT THE LOOP WAS NO LONGER ATTACHED TO THE TIP OF THE 24FR RESECTION LOOP. THE SURGEON AND STAFF SEARCHED FOR THE PIECE OF LOOP THROUGH THE CYSTOSCOPE, IN THE SPECIMEN, AND IN THE SUCTION SCREEN. AFTER AN EXTENSIVE SEARCH THE SURGEON AND STAFF WAS STILL WERE UNABLE TO FIND THE PIECE OF LOOP. NO X-RAY WAS PERFORMED AS THE SURGEON FELT THE LOOP FRAGMENT WOULD NOT BE VISIBLE DO TO THE SIZE. THE OPERATING ROOM SUPERVISOR VERIFIED NO X-RAY WAS REQUIRED POST- PROCEDURE DUE TO THE SIZE OF THE OBJECT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639049 ↗
• MalfunctionJan 2, 2018Break

  ELECTRODE CUTTING LOOP 24 FR BROKE DURING PROCEDURE, 2 LOOPS BROKE. NO HARM TO PT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7159789 ↗