Olympus A22027ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761029353), received between Sep 12, 2022 and Dec 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Break; Dent in Material; Material Twisted/Bent; Failure to Seal; Break; Dent in Material; Material Twisted/Bent; Failure to Seal

  IT WAS REPORTED THAT DURING A CYSTOSCOPY, THE SUBJECT DEVICE HAD EXHIBITED NOT SEALING, A COUPLE OF DENTS, IT WAS BENT AND THE LOCK WAS BROKEN. THIS ISSUE RESULTED IN DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043402 ↗
• InjuryDec 30, 2024Break; Dent in Material; Material Twisted/Bent; Failure to Seal; Break; Dent in Material; Material Twisted/Bent; Failure to Seal

  IT WAS REPORTED THAT DURING A CYSTOSCOPY, THE SUBJECT DEVICE HAD EXHIBITED NOT SEALING, A COUPLE OF DENTS, IT WAS BENT AND THE LOCK WAS BROKEN. THIS ISSUE RESULTED IN DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043344 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A STUDY TITLED ¿MONOPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE VERSUS HOLMIUM LASER ENUCLEATION IN MEN WITH PROSTATE VOLUME GREATER THAN 100 ML¿. THIS RETROSPECTIVE STUDY WAS AIMED TO COMPARE THE SAFETY AND EFFICACY OF MONOPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE (M-TURP) AND HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) FOR PROSTATE SIZE >100 ML. THIRTEEN PATIENTS UNDERWENT M-TURP (GROUP 1), AND 27 UNDERWENT HOLEP (GROUP 2). THERE WERE MORE COMPLICATIONS IN GROUP 1 THAN GROUP 2, ESPECIALLY FOR PATIENTS UNDERGOING TRANSFUSION AND WITH HYPONATREMIA (2 IN GROUP 1 AND 0 IN GROUP 2). AT 3-MONTH FOLLOW-UP, THE INTERNATIONAL PROSTATE SYMPTOM SCORE, QUALITY OF LIFE SCORE, AND RESIDUAL URINE VOLUME REVEALED NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS. THIS STUDY CONCLUDED THAT M-TURP AND HOLEP IN MEN WITH PROSTATE VOLUME GREATER 100ML HAD SIMILAR OPERATIVE TIME, ADMISSION DAYS AND POSTOPERATIVE FUNCTIONAL OUTCOMES. HOWEVER, HIGHER TRANSFUSION RATES AND POSTOPERATIVE HYPONATREMIA WERE NOTED IN THE M-TURP GROUP COMPARING TO THE HOLEP GROUP. THE MODEL NUMBER OF THE PRODUCT (26-FR RESECTOSCOPE) WAS UNKNOWN, BUT A REPRESENTATIVE PRODUCT (A22027A) WAS CHOSEN FOR PROCES

  Patient problems: Hyponatremia; Urethral Stenosis/Stricture; Urinary Incontinence

  MAUDE report 15400848 ↗