Olympus WA22621SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14042761085172), received between Mar 31, 2025 and Jun 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 4, 2022Open, Classified

   An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

   Z-0424-2023 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WHEN THE PACKAGE WAS OPENED APPEARED TO HAVE PINHOLES IN THE TRIANGLE SHAPED AREA. THERE WERE NO REPORTS OF PATIENTS¿ HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286443 ↗
• MalfunctionJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THE SUBJECT DEVICE PACKAGE APPEARED TO HAVE PIN HOLES IN THE TRIANGLE SHAPED AREA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283239 ↗
• MalfunctionMar 31, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THE RESECTION ELECTRODE WAS RECEIVED WITH A TRIANGLE SHAPED HOLE IN ITS PACKAGING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT AS THIS OCCURRED AT INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730430 ↗
• MalfunctionMar 31, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Material Twisted/Bent

  IT WAS REPORTED THE RESECTION ELECTRODE WAS RECEIVED WITH A TRIANGLE SHAPED HOLE IN ITS PACKAGING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT AS THIS OCCURRED AT INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730416 ↗