Olympus A22041TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04042761020978), received between Jan 16, 2019 and May 11, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 11, 2025Open, Classified

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

   Z-1442-2026 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionMay 11, 2026Break; Material Separation

  IT WAS REPORTED THE RESECTION SHEATH WAS IN USE AND A DAMAGE HAD OCCURRED DURING A TRANSURETHRAL RESECTION, THERAPEUTIC PROCEDURE. A FRAGMENT FELL OFF WHILE THE ELECTRODE WAS BEING MANIPULATED INSIDE THE BLADDER. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137119 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE SHEATH WAS BROKEN. THE ISSUE WAS FOUND DURING SET UP FOR AN UNSPECIFIED PROCEDURE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017061 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THE ENDOSCOPE SHEATH EXHIBITED A BROKEN CERAMIC TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967802 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE¿SUBJECT DEVICE HAD BROKEN CERAMIC TIP. THE ISSUE WAS FOUND DURING INSPECTION FOR USE THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893543 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THE RESECTION SHEATH TIP BROKE OFF WHEN BOX WAS OPENED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704656 ↗
• InjuryApr 22, 2022Break; Break

  OLYMPUS WAS NOTIFIED OF THE EVENT FROM THE CUSTOMER VIA MW5107602. DURING A CYSTOSCOPY TRANSURETHRAL RESECTION OF THE PROSTATE, THE TIP OF THE SWIVEL OBTURATOR ON THE SCOPE BROKE OFF IN THE PATIENT. THE BROKEN TIP WAS RETRIEVED AND NO PIECES WERE LEFT IN THE PATIENT. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE. THE CUSTOMER REPORTED THIS MALFUNCTION OCCURRED AT THE END OF THE PROCEDURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PROCEDURAL DELAY, NO CHANGE IN THE PATIENT'S TREATMENT COURSE DUE TO THE MALFUNCTION AND NO POST-OPERATIVE ISSUES WITH THE PATIENT DUE TO THIS ISSUE. THE CUSTOMER REQUESTED A RE-EDUCATION ON THE PROPER HANDLING OF THIS DEVICE AND THERE HAVE NOT BEEN ANY FURTHER ISSUES SINCE TRAINING.

  Patient problems: Foreign Body In Patient

  MAUDE report 14190520 ↗
• InjuryApr 22, 2022Break

  OLYMPUS WAS NOTIFIED OF THE EVENT FROM THE CUSTOMER VIA MW5107602. DURING A CYSTOSCOPY TRANSURETHRAL RESECTION OF THE PROSTATE, THE TIP OF THE SWIVEL OBTURATOR ON THE SCOPE BROKE OFF IN THE PATIENT. THE BROKEN TIP WAS RETRIEVED AND NO PIECES WERE LEFT IN THE PATIENT. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE. THE CUSTOMER REPORTED THIS MALFUNCTION OCCURRED AT THE END OF THE PROCEDURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PROCEDURAL DELAY, NO CHANGE IN THE PATIENT'S TREATMENT COURSE DUE TO THE MALFUNCTION AND NO POST-OPERATIVE ISSUES WITH THE PATIENT DUE TO THIS ISSUE. THE CUSTOMER REQUESTED A RE-EDUCATION ON THE PROPER HANDLING OF THIS DEVICE AND THERE HAVE NOT BEEN ANY FURTHER ISSUES SINCE TRAINING.

  Patient problems: Foreign Body In Patient

  MAUDE report 14190477 ↗
• MalfunctionSep 20, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE IT WAS NOTICED THAT THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH WAS MISSING. THE MISSING FRAGMENT COULD NOT BE LOCATED AND IT IS UNCLEAR WHETHER IT WAS ALREADY MISSING DURING THE PRE-USE INSPECTION OR WHETHER THE FRAGMENT BROKE OFF INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493931 ↗
• MalfunctionAug 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TERRITORY SALES MANAGER OBTAINED ADDITIONAL INFORMATION FROM THE PHYSICIAN WHO REPORTED THE EVENT WAS OBSERVED AT THE END OF A TRANSURETHRAL RESECTION OF A BLADDER TUMOR PROCEDURE. THE PROCEDURE WAS PROLONGED BY 15 MINUTES.AS A SINGLE PIECE FELL OFF INSIDE THE PATIENT AND WAS RETRIEVED USING A CYSTOSCOPE AND A BASKET. THE PATIENT WAS INSPECTED AND CONFIRMED NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12397234 ↗
• MalfunctionApr 19, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, IT WAS NOTICED THAT THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH WAS MISSING. IT COULD NOT BE CONCLUSIVELY DETERMINED WHETHER THE FRAGMENT HAD FALLEN INTO THE PATIENT DURING THE PROCEDURE AND THE MISSING FRAGMENT COULD NOT BE LOCATED. HOWEVER, THE INTENDED PROCEDURE WAS 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

  MAUDE report 11684275 ↗
• MalfunctionMar 7, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE DISTAL TIP OF THE DEVICE PARTIALLY BROKE OFF INTO MULTIPLE PIECES INSIDE THE PATIENT¿S BLADDER. THE USER FACILITY REPORTED THEY WERE UNABLE TO RETRIEVE ALL THE DEVICE FRAGMENTS, HOWEVER, THERE AS NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8401441 ↗
• MalfunctionJan 16, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE FRAGMENT WAS REDUCED TO SMALL PIECES USING A LASER AND RETRIEVED AFTERWARDS. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251871 ↗