Olympus A22040TRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04042761029360), received between Dec 20, 2018 and May 1, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. Nov 11, 2025Open, Classified

   Complaints of the ceramic tip of the resection sheath breaking have been received.

   Z-1440-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE BEAK AT THE TIP OF INNER SHEATH WAS DAMAGED. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER DEVICE, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055566 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE SHEATH BROKE OFF. THE ISSUE WAS DISCOVERED DURING REPROCESSING. NO HARM REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017041 ↗
• MalfunctionApr 6, 2026Degraded

  THE ENDOSCOPE SHEATH WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE BAKELITE LINER WAS DAMAGED DURING REPROCESSING. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A FRACTURED INSULATION TIP WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792644 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THE DURING A THERAPEUTIC PROCEDURE THE INNER SHEATH BEAK BENT INSIDE THE BODY AND THE MATERIAL FELL OFF. THE BEAK WAS RETRIEVED AND SWITCHED OUT FOR ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237438 ↗
• MalfunctionMay 28, 2025Break; Break

  CORRECTION TO B5 FOR INFORMATION INADVERTENTLY LEFT OUT OF PREVIOUS REPORT:'THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095765 ↗
• MalfunctionSep 17, 2024Break; Break

  DURING THE DEVICE EVALUATION, THE INNER SHEATH EXHIBITED THE CERAMIC TIP BROKEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242195 ↗
• InjurySep 3, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THE SHEATH HAD A CRACK IN THE INNER SHEATH SLEEVE, WHICH FELL OFF INTO THE BLADDER. THE FALLEN PART WAS RETRIEVED WITH FORCEPS. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC THERAPEUTIC TURIS-BT PROCEDURE, AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20124850 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THE SHEATH HAD A BROKEN CERAMIC TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938161 ↗
• InjuryFeb 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE PATIENT BEING TRANSFERRED TO ANOTHER HOSPITAL TO RETRIEVE THE FALLEN DEVICE PIECE FROM THE BLADDER, THE INNER SHEATH WAS REPLACED, AND THE TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS COMPLETED. DURING THE TURP, THERE WAS AN UNSPECIFIED PROCEDURAL DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA IN AN ATTEMPT TO TROUBLESHOOT THE ISSUE. CURRENTLY, THE PATIENT IS REPORTEDLY IN A PERFECT STATE OF HEALTH AND BOTH HOSPITALS ARE CONDUCTING FOLLOW UP WITH HIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803300 ↗
• InjuryAug 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING HOLMIUM LASER ENUCLEATION OF THE PROSTATE SURGERY, THIS INNER SHEATH BEAK FELL OFF IN THE BLADDER AND WAS COLLECTED IMMEDIATELY WITH GRASPING FORCEPS. THE BEAK WAS BROKEN BUT IT WAS NOT SHARP, AS REPORTED. THE PHYSICIAN EXPLAINED THAT IT WAS USED NORMALLY. NO PROLONGATION OF PROCEDURE, NO ADDITIONAL ANESTHESIA AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO PROBLEM OBSERVED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564540 ↗
• MalfunctionJan 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO OLYMPUS THAT THE BEAK OF THE RESECTOSCOPE FELL INTO THE BLADDER DURING THE TURIS OPERATION. IT WAS RETRIEVED WITH FOREIGN BODY FORCEPS. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210045 ↗
• MalfunctionNov 22, 2022Break; Break

  AN OLYMPUS SALES REP REPORTED ON BEHALF OF THE CUSTOMER, CERAMIC TIP OF INNER SHEATH FOR 26FR. OUTER SHEATH WITH A22085A BROKE OFF IN PATIENT. THE INTENDED PROCEDURE WAS A THERAPEUTIC CYSTOSCOPY. THERE WAS A DELAY IN PROCEDURE WHEN MEDICAL STAFF IRRIGATED THE PATIENT FOR RETRIEVAL OF BROKEN PIECES. ALL PIECES WERE PLACED TOGETHER TO FORM A COMPLETE TIP. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE LASER INSCRIPTION WAS FADED; THEREFORE, THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848374 ↗
• MalfunctionSep 20, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TUR-BT) PROCEDURE, THE CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH BROKE OFF AND FELL INSIDE INTO THE PATIENT'S BLADDER. THE BROKEN OFF FRAGMENT COULD BE RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. FURTHERMORE, THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454746 ↗
• InjuryMay 25, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE DISASSEMBLED IN THE PATIENT'S CAVITY. IT IS UNKNOWN HOW THE SUBJECT DEVICE WAS RETRIEVED FROM THE PATIENT'S CAVITY OR IF THERE WAS A PROCEDURAL DELAY DUE TO THIS ISSUE. ADDITIONAL INFORMATION IS BEING REQUESTED OF THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 14497873 ↗
• MalfunctionFeb 6, 2022Break; Fracture; Break; Fracture

  OLYMPUS (OMS) WAS INFORMED BY THE DOCTOR AT THE USER FACILITY THAT ¿ALMOST FINISHING A RESECTION, THE DOCTOR NOTICED THAT THERE WAS A BLACK FRAGMENT IN THE BLADDER, THE DOCTOR STOPPED AND CONFIRMED THAT THE BEVEL OF THE INNER SLEEVE HAD FRACTURED INSIDE THE PATIENT, THE DOCTOR REMOVED IT AND FINISHED THE PROCEDURE. THERE WAS NO PATIENT DAMAGE OR PORT -SURGICAL PROBLEMS DERIVED FROM THE EVENT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467676 ↗
• MalfunctionJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CERTIFIED SURGICAL TECHNOLOGIST AT THE USER FACILITY FURTHER REPORTED THE MALFUNCTION OCCURRED DURING THE MIDDLE OF AN UNSPECIFIED PROCEDURE. WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, THERE WAS A HALF HOUR DELAY AS ANOTHER DEVICE WAS OBTAINED AND USED TO COMPLETE THE INTENDED PROCEDURE. NO DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215242 ↗
• MalfunctionMay 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE STERILE PROCESSING DEPARTMENT MANAGER AT THE USER FACILITY REPORTED, DURING THE BEGINNING OF AN UNSPECIFIED THERAPEUTIC PROCEDURE, 2 PIECES OF THE CERAMIC TIP FELL OFF THE DISTAL END OF THE INNER SHEATH AND FELL INSIDE THE PATIENT'S BLADDER BUT BOTH PIECES WERE RETRIEVED. NO X-RAY OR CT SCAN WAS PERFORMED. THERE WAS MODERATE BLEEDING. THERE WAS A DELAY BUT IT WAS UNKNOWN HOW LONG. THE PROCEDURE WAS COMPLETED USING A SIMILAR INNER SHEATH (SAME MODEL). NO OTHER DEVICES WERE REPLACED. NO PATIENT DEATH, INJURY OR INFECTION WAS REPORTED. PRIOR TO USE, THE DEVICE WAS INSPECTED BEFORE USE AND NO ABNORMALITIES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794495 ↗
• MalfunctionJan 18, 2021Unintended Ejection; Unintended Ejection

  AN OLYMPUS REPRESENTATIVE REPORTED THAT A USER FACILITY WAS USING AN INNER SHEATH DURING A PROCEDURE WHEN THE BEAK BECAME DISLODGED. THE CERAMIC TIP BROKE OFF INTO THE PATIENT DURING A RESECTION PROCEDURE. THE TIP WAS RETRIEVED USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER RESECTION SHEATH. NO DEATH, INJURY, OR INFECTION OCCURRED AS A RESULT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

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

  MAUDE report 11189386 ↗
• MalfunctionJul 31, 2020Break; Break

  IT WAS REPORTED THAT A PIECE OF THE CERAMIC PART OF THE DISTAL TIP BROKE OFF WHILE DURING INSERTION INTO THE PATIENT. THE TIP WAS RETRIEVED WITH NO PATIENT INJURY. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10352139 ↗
• MalfunctionMar 11, 2020Break; Break

  THE TECHNICAL ASSISTANCE GROUP BECAME AWARE THAT THE INNER SHEATH WAS OBSERVED TO BE BROKEN FOLLOWING A TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE. IT WAS UNKNOWN IF THE INNER SHEATH HAD BEEN BROKEN BEFORE, DURING OR AFTER PROCEDURE. THE PROCEDURE WAS COMPLETED. NO DEVICE FRAGMENTS WERE FOUND INSIDE THE PATIENT AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820657 ↗
• MalfunctionApr 19, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A CYSTOSCOPY PROCEDURE, THE DOCTOR LOCATED AND REMOVED A BROKEN PORTION OF THE INNER SHEATH. REPORTEDLY, THE DEVICE FRAGMENT REMAINED IN THE PATIENT AFTER UNDERGOING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) ON (B)(6) 2018 OR (B)(6) 2018. THE DOCTOR WAS UNSURE IF THE PATIENT SUSTAINED ANY INJURY; HOWEVER, REPORTED THAT THE PATIENT COULD¿VE EXPERIENCED SOME BLEEDING. THE INTENDED PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8531432 ↗
• MalfunctionMar 28, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL VAPORIZATION OF PROSTATE (TUVP) WITH THE PLASMA BUTTON PROCEDURE, PIECES FROM THE SHEATH TIP BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. IT UNKNOWN IF THE DEVICE FRAGMENTS WERE RETRIEVED. THERE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462765 ↗
• MalfunctionDec 20, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE, THE BLACK TIP OF THE INNER SHEATH BROKE OFF AND FELL INSIDE THE PATIENT¿S BLADDER. THE DEVICE FRAGMENT WAS RETRIEVED WITH AN UNKNOWN DEVICE. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT NO OTHER EQUIPMENT WAS REPLACED DURING THE PROCEDURE, THE SHEATH DID NOT EXPERIENCE ANY EXTERNAL IMPACT OR FALLS PRIOR TO THE PROCEDURE AND WAS INSPECTED WITH NO ANOMALIES NOTED. THE SHEATH ALSO HAD BEEN LUBRICATED PRIOR TO ASSEMBLY WITH OTHER EQUIPMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188045 ↗