PK TECHNOLOGY 910000PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925034778), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K031078); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2020Activation Failure; Activation Failure

  THE CUSTOMER CONTACTED OLYMPUS TO REPORT THE DEVICE EXHIBITED NO OUTPUT WHEN TESTED PRIOR TO USE (OUTSIDE OF THE PATIENT) IN A GYNECOLOGICAL LAPAROSCOPIC PROCEDURE. THE DEVICE WAS REPLACED WITH A NON OLYMPUS REUSABLE MOLLY FORCEP. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10978886 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031078. One submission often covers many models, so check the product and lot details in each record.

• Z-0100-2015 · Aug 27, 2014 · Terminated
  GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Fo