PlasmaKinetic 784515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925039513), received between Mar 18, 2021 and Apr 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTRODE PROBES EXHIBITED CHARRED MARKS ON THE CUTTING WIRE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023602 ↗
• MalfunctionNov 10, 2021Melted; Melted

  THE CUSTOMER¿S OLYMPUS SALES REPRESENTATIVE REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CABLE WAS MELTED AT THE JUNCTION WITH THE SCOPE ON THE PK FRONT LOADING SUPERSECT LOADING ELECTRODE DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789195 ↗
• MalfunctionOct 25, 2021Break; Output Problem; Break; Output Problem

  AS REPORTED, UPON INITIAL CLINICAL USE, THE DEVICE 784515 SUPERSECT LOOP EXHIBITED AN ERROR MESSAGE OUTPUT SHORTAGE ON THE GENERATOR 7440000. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER MODALITY. THE FOLLOWING DAY, ANOTHER 784515 SUPERSECT LOOP WAS USED ON THE SAME GENERATOR 744000 AND DID NOT HAVE AN ERROR. THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND INTERNAL WIRING APPEARED TO BE BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694635 ↗
• MalfunctionMar 18, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE ELEMENT CAUSED THE GENERATOR TO RESET. AN ERROR CODE 100 OCCURRED. THERE WAS A THREE MINUTES DELAY HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT IMPACT, NO USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515984 ↗