Olympus A22026ARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04042761029346), received between Jul 2, 2018 and Sep 29, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  The customer returned the reusable Endoscope sheath for a separate issue. During the device analysis, it was observed that the distal end is chipped. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933059 ↗
• InjurySep 2, 2026Overheating of Device

  Patient problems: Urethral Stenosis/Stricture; Urinary Incontinence

  MAUDE report 50574057 ↗
• MalfunctionDec 23, 2025Loss of or Failure to Bond; Break; Fracture; Detachment of Device or Device Component; Loss of or Failure to Bond; Break; Fracture; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INNER SHEATH CERAMIC TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878341 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390609 ↗
• MalfunctionAug 29, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING SET UP / INSPECTION FOR USE, THE SUBJECT OUTER SHEATH STOPCOCK DEVICE HAD BLACK RESIDUE ON THE INSTRUMENTS AND REJECTING TRAYS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922071 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472804 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE PATIENT FELT LIGHT CURRENT LEAKAGE FROM THE WORKING ELEMENT WITHOUT ANY INJURY. IT WAS LATER REPORTED THAT WITHIN AROUND 2 MONTHS AFTER THE PROCEDURE USING THE SUBJECT DEVICE, THE PATIENT DEVELOPED URETHRAL STRICTURES. THE STRICTURES WERE LATER TREATED BY THE DOCTOR AND THE PATIENT IS REPORTEDLY FINE AFTER THE TREATMENT. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 20248962 ↗
• MalfunctionFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE HAD THE LOCK PART COME LOOSE DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769067 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A PLANNED LASER PROSTATE RESECTION ON (B)(6) 2023, A NON-OLYMPUS LASER WAS BEING USED INITIALLY BUT DUE TO SOME TECHNICAL ISSUE WITH THE LASER EQUIPMENT, THE DOCTOR USED THE OLYMPUS RESECTION SET WITH A NON-OLYMPUS KNIFE. AFTER USING THE DEVICE FOR NEARLY 20 TO 25 MINUTES, THE DOCTOR HAD SHIFTED TO A DIFFERENT NON-OLYMPUS LASER AND COMPLETED THE PROCEDURE WITH NO COMPLICATIONS AT THAT POINT. AT A LATER DATE ON (B)(6) 2023, THE CATHETER WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS OKAY AT THAT TIME. ON (B)(6) 2023, THE PATIENT HAD A FOLLOW-UP VISIT AND PER THE DOCTOR THE PATIENT WAS FINE. ON (B)(6) 2023, THE PATIENT NOTICED A "URINE LEAK" AND NOTIFIED A DOCTOR. ON (B)(6) 2023, THE OPERATING DOCTOR BECAME AWARE AND RECEIVED PICTURES THAT THE PATIENT PROVIDED. THE DOCTOR ADVISED FOR A NEEDED URETHRAL RECONSTRUCTION AND NO OTHER COMPLICATIONS. THIS EVENT REQUIRES 6 REPORTS. RELATED PATIENT IDENTIFIERS: (B)(6) / MODEL: WB91051W SN: (B)(6); (B)(6) / MODEL:WA22366A SN: (B)(6); (B)(6) / MODEL:A22040A SN: (B)(6); (B)(6) / MODEL: A22026A SN: (B)(6); (B)(6) / MODEL: WA22355C SN: UNKNOWN; (B)(6) / MODEL: WA00014A SN:

  Patient problems: Urinary Incontinence

  MAUDE report 18040481 ↗
• InjuryMar 17, 2023Obstruction of Flow; Obstruction of Flow

  OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE USER EXPERIENCED POOR OUTFLOW, WHICH RESULTED IN POOR VISION AND THE EQUIPMENT WAS EXCHANGED TO A COMPETITORS EQUIPMENT. THIS LED TO A PROLONGATION OF APPROXIMATELY 30-40 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITORS EQUIPMENT. AN OLYMPUS REPRESENTATIVE WAS ONSITE DURING 4 SIMILAR PROCEDURES TO HELP FIX THE PROBLEM BUT COULD NOT SUCCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563374 ↗
• InjuryMar 17, 2023Obstruction of Flow; Obstruction of Flow

  OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE USER EXPERIENCED POOR OUTFLOW, WHICH RESULTED IN POOR VISION AND THE EQUIPMENT WAS EXCHANGED TO A COMPETITORS EQUIPMENT. THIS LED TO A PROLONGATION OF APPROXIMATELY 30-40 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITORS EQUIPMENT. AN OLYMPUS REPRESENTATIVE WAS ONSITE DURING 4 SIMILAR PROCEDURES TO HELP FIX THE PROBLEM BUT COULD NOT SUCCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563354 ↗
• InjuryMar 17, 2023Obstruction of Flow; Obstruction of Flow

  OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE USER EXPERIENCED POOR OUTFLOW, WHICH RESULTED IN POOR VISION AND THE EQUIPMENT WAS EXCHANGED TO A COMPETITORS EQUIPMENT. THIS LED TO A PROLONGATION OF APPROXIMATELY 30-40 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITORS EQUIPMENT. AN OLYMPUS REPRESENTATIVE WAS ONSITE DURING 4 SIMILAR PROCEDURES TO HELP FIX THE PROBLEM BUT COULD NOT SUCCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563328 ↗
• InjuryMar 17, 2023Obstruction of Flow; Obstruction of Flow

  OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE USER EXPERIENCED POOR OUTFLOW, WHICH RESULTED IN POOR VISION AND THE EQUIPMENT WAS EXCHANGED TO A COMPETITORS EQUIPMENT. THIS LED TO A PROLONGATION OF APPROXIMATELY 30-40 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITORS EQUIPMENT. AN OLYMPUS REPRESENTATIVE WAS ONSITE DURING 4 SIMILAR PROCEDURES TO HELP FIX THE PROBLEM BUT COULD NOT SUCCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563280 ↗
• InjuryMar 7, 2023Obstruction of Flow; Obstruction of Flow

  OLYMPUS WAS INFORMED THAT DURING THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE USER EXPERIENCED POOR OUTFLOW, WHICH RESULTED IN POOR VISION AND THE EQUIPMENT WAS EXCHANGED TO A COMPETITORS EQUIPMENT. THIS LED TO A PROLONGATION OF APPROXIMATELY 30-40 MINUTES. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITORS EQUIPMENT. AN OLYMPUS REPRESENTATIVE WAS ONSITE DURING 5-6 SIMILAR PROCEDURES TO HELP FIX THE PROBLEM BUT COULD NOT SUCCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494998 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED ABOUT THE LITERATURE STUDY ¿OUTCOMES OF SURGICAL HYSTEROSCOPY: 25 YEARS OF OBSERVATIONAL STUDY¿. THE AIM OF THIS STUDY WAS TO ANALYSE THE COMPLICATIONS ARISING FROM OPERATIVE HYSTEROSCOPIES PERFORMED DURING THE LAST 25 YEARS AT HOSPITAL PARC TAULÍ DE SABADELL AND TO DESCRIBE THEIR DIFFERENCES ACCORDING TO THE TYPE OF PROCEDURE PERFORMED. 3.063 OPERATIVE HYSTEROSCOPIES WERE PERFORMED, 52.7% WERE POLYPECTOMIES AND 31.5% WERE MYOMECTOMIES. MYECTOMIES HAD THE HIGHEST INCIDENCE OF COMPLICATIONS, AT 14%, FOLLOWED BY SEPTOLYSIS, AT 6.9%. THE MOST COMMON COMPLICATIONS WERE MECHANICAL (52%). MYOMECTOMIES HAD SEVEN TIMES HIGHER RISK THAN POLYPECTOMIES OF DISTENSION-MEDIUM COMPLICATIONS BUT THREE TIMES LOWER RISK OF MECHANICAL COMPLICATION. THE HIGHEST INCIDENCE OF COMPLICATIONS OCCURRED IN TYPE I MYOMAS AND THOSE LARGER THAN 3 CM. IF STUDY DEFINES FLUID-BALANCE COMPLICATIONS AS ONLY THOSE PATIENTS WHO ABSORBED MORE THAN 1.5 L AND DEVELOPED RELATED SYMPTOMS, OVERALL COMPLICATION RATE, INCLUDING ALL MECHANICAL COMPLICATIONS, WAS 5.6%. THE TYPE OF ADVERSE EVENTS OCCURRED DURING THE STUDY AT HAND ARE CERVICAL TEAR, UTERINE PERFORATION, FALSE CERVICAL ROUTE, VAGINAL TEAR, FAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15614183 ↗
• MalfunctionOct 8, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE, THE CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH BROKE OFF INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165547 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED BY THE DOCTOR AT THE USER FACILITY THAT THE CONNECTION WHERE THE HF RESECTION INNER AND OUTER SHEATH MEET (A22040A AND A22026A) HAS THE POTENTIAL TO TEAR THE URETHRA OF THE PATIENTS. THE DOCTOR REPORTED THAT THE EVENT HAS HAPPENED BEFORE BUT THE DOCTOR DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT OR PATIENT. ADDITIONALLY, THE DOCTOR REPORTED THAT THEY BELIEVE IT IS ONE RESECTOSCOPE SET OF SHEATHS THAT CAUSED THE REPORTED EVENT. THE USER FACILITY UTILIZES 3RD PARTY REPAIRS FOR THEIR EQUIPMENT. THIS IS 2 OF 2 DEVICES.

  Patient problems: Tissue Damage

  MAUDE report 8804648 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED BY THE DOCTOR AT THE USER FACILITY THAT THE CONNECTION WHERE THE HF RESECTION INNER AND OUTER SHEATH MEET (A22040A AND A22026A) HAS THE POTENTIAL TO TEAR THE URETHRA OF THE PATIENTS. THE DOCTOR REPORTED THAT THE EVENT HAS HAPPENED BEFORE BUT THE DOCTOR DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT OR PATIENT. ADDITIONALLY, THE DOCTOR REPORTED THAT THEY BELIEVE IT IS ONE RESECTOSCOPE SET OF SHEATHS THAT CAUSED THE REPORTED EVENT. THE USER FACILITY UTILIZES 3RD PARTY REPAIRS FOR THEIR EQUIPMENT. THIS IS 2 OF 2 DEVICES.

  Patient problems: Tissue Damage

  MAUDE report 8804572 ↗
• MalfunctionFeb 28, 2019Break; Break

  OLYMPUS RECEIVED A MEDWATCH REPORT WHICH STATES THAT DURING AN UNSPECIFIED PROCEDURE, THE CERAMIC TIP FROM THE SHEATH BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. THE DEVICE FRAGMENT WAS COMPLETELY RETRIEVED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380684 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM IN SALINE (TCRIS) PROCEDURE, THE PATIENT SUSTAINED A PERFORATION OF THE UTERUS. IT IS SUSPECTED THAT THIS INJURY WAS CAUSED BY EXCESSIVE FORCE APPLIED ON THE RESECTOSCOPE. THE PROCEDURE WAS THEN CONVERTED TO A LAPAROSCOPIC PROCEDURE TO TREAT THE PERFORATION. NO FURTHER INFORMATION WAS PROVIDED BUT NONE OF THE OLYMPUS MEDICAL DEVICES SHOWED ANY MALFUNCTION AND THE PROCEDURE WAS REPORTEDLY COMPLETED AFTER THE INTERVENTION.

  Patient problems: Internal Organ Perforation

  MAUDE report 7654121 ↗