PK TECHNOLOGY 3005PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925036000), received between Nov 1, 2023 and Aug 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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-1642-2026 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionAug 20, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE SUBJECT DEVICE INSTRUMENT DID NOT WORK; IT COULD NOT ACTIVATE ENERGY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850323 ↗
• MalfunctionNov 1, 2023Loss of Power; Loss of Power

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PKS CUTTING FORCEPS HAS NO ENERGY WHEN ACTIVATED AT FULL RANGE. THE ISSUE WAS FOUND DURING THE THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHICH WAS COMPLETED WITH NO DELAY AND WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051832 ↗

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-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-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-1638-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bi
• 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-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
• 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-2541-2024 · 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