PlasmaKinetic 714941Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925039551), received between Feb 20, 2023 and Dec 18, 2023 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHEN USING A PK SUPER LOOP, THE HEAD OF THE RESECTION LOOP FELL INTO THE BLADDER. AN ENDOSCOPE WAS USED TO SEARCH FOR THE LOOP, BUT IT WAS NOT FOUND. THE THERAPEUTIC PROCEDURE (TRANSURETHRAL RESECTION OF THE PROSTATE) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A PROCEDURAL DELAY OF ABOUT 30 MINUTES. THE PATIENT WAS DISCHARGED HOME WITH NO ADVERSE REACTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350547 ↗
• MalfunctionFeb 20, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BIPOLAR RESECTION LOOP BROKE WHILE BEING USED INSIDE THE PATIENT. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (TURP - TRANSURETHRAL RESECTION OF THE PROSTATE), THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE FRAGMENT FELL INTO THE DEVICE (NOT THE PATIENT) AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401985 ↗