Olympus WA22332DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761051702), received between Aug 29, 2018 and Jul 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "EN BLOC RESECTION VERSUS CONVENTIONAL TURBT FOR T1HG BLADDER CANCER: A PROPENSITY SCORE-MATCHED ANALYSIS." THIS STUDY AIMED TO CLARIFY THE PERIOPERATIVE, ONCOLOGIC, AND PATHOLOGIC OUTCOMES OF EN BLOC RESECTION OF BLADDER TUMORS (ERBT) FOR PATIENTS WITH PT1 BLADDER CANCER (BCA) COMPARED WITH CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMORS (CTURBT) IN A LARGE MULTICENTER RETROSPECTIVE COHORT USING PROPENSITY SCORE-MATCHED (PSM) ANALYSIS. THE PSM COHORT CONSISTED OF 202 PATIENTS: 101 IN CTURBT GROUP AND 101 IN ERBT GROUP. COMPLICATIONS WERE DETECTED IN SIX PATIENTS IN THE CTURBT GROUP AND FOUR PATIENTS IN THE ERBT GROUP. THE 3-YEAR RFS ESTIMATES WERE 59.3% [95% CONFIDENCE INTERVAL (CI) 48.2¿68.8] IN THE CTURBT GROUP, AND 65.8% (95% CI 54.0¿75.2) IN THE ERBT GROUP (P = 0.7). THERE WERE NO DIFFERENCES IN THE 3-YEAR MFS AND THE 3-YEAR CSS ESTIMATES BETWEEN THE TWO GROUPS. THE DETECTION RATE FOR MM¿VP WAS SIGNIFICANTLY HIGHER IN PATIENTS WHO UNDERWENT ERBT (CTURBT: 77% VERSUS ERBT: 99%, P\0.001). ERBT IMPROVES THE QUALITY OF RESECTION AND SPECIMEN, YIELDING LESS RESIDUE ON RETURN AND YIELDING SUPERIOR HISTOPATHOLOGIC INFORMATION SU

  Patient problems: Perforation

  MAUDE report 17393586 ↗
• MalfunctionAug 29, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED HYSTEROSCOPY PROCEDURE, A PART OF THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND A FRAGMENT FELL INSIDE THE PATIENT'S BODY AND REMAINED THERE, SINCE IT COULD NOT BE LOCATED. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS ALSO NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7825979 ↗