OLYMPUS 3005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821925035881), received between May 10, 2021 and Sep 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K023492); they may or may not involve this specific model.

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. Feb 25, 2026Open, Classified

   Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

   Z-1638-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Jul 1, 2024Open, Classified

   Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

   Z-2541-2024 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000347 ↗
• MalfunctionMay 1, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942350 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE SEAL WAS BROKEN. THE STERILE DEVICE WAS COMPROMISED. THE UNIT LOST ITS STERILE INTEGRITY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942076 ↗
• MalfunctionApr 28, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922538 ↗
• MalfunctionMar 27, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE POWERSEAL WOULD NOT OPERATE AFTER CONNECTION. THE ISSUE WAS FOUND DURING A THERAPEUTIC MYOMECTOMY PROCEDURE AND COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715509 ↗
• MalfunctionMay 10, 2021Energy Output Problem; Energy Output Problem

  OLYMPUS WAS INFORMED OF A REPORT THAT THE INSTRUMENT CONTINUED TO SEAL EVEN WHEN THE FOOT PEDAL WAS RELEASED (DEACTIVATED). THE PROBLEM OCCURRED DURING A LAPAROSCOPIC EUG PROCEDURE. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED, AFTER A SHORT DELAY OF UNSPECIFIED TIME, USING BIPOLAR FORCEPS FROM A GYNECOLOGICAL LAPAROSCOPY SET AND SCISSORS. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803250 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023492. One submission often covers many models, so check the product and lot details in each record.

• Z-1639-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Ever
• Z-1643-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended
• Z-1642-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be pas
• Z-1644-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be p
• Z-2540-2024 · Jul 1, 2024 · Open, Classified
  The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved u
• Z-2542-2024 · Jul 1, 2024 · Open, Classified
  The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved u