PK TECHNOLOGY 970010PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925038097), received between Jun 3, 2022 and Jun 3, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K081766); 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.

• MalfunctionJun 3, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, THE TIP OF THE INSTRUMENT CAME OFF IN THE MIDDLE OF THE PROCEDURE. IT WAS REMOVED FROM THE PATIENT WITHOUT ANY INJURY. THE INSTRUMENT WAS ONLY USED FOR ABOUT 10 MINUTES. THE INTENDED PROCEDURE WAS A THERAPEUTIC TLH ( TOTAL LAPAROSCOPIC HYSTERECTOMY ). THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14587590 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081766. One submission often covers many models, so check the product and lot details in each record.

• Z-2380-2021 · Jun 9, 2021 · Terminated
  Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open sur