UltraPulse® Encore™ OfficeRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109140490), received between Mar 13, 2019 and Jun 4, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 4, 2019Activation Problem; Activation Problem

  THE SYSTEM TURNED OFF DURING A PROCEDURE. THE PATIENT WAS IN FULL ANESTHESIA AND WAS AWAKENED BY THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8665882 ↗
• InjuryMar 13, 2019Device Handling Problem; Device Handling Problem

  USER FACILITY REPORTED THAT THE PLANNED PROCEDURE WITH THE SUBJECT DEVICE COULD NOT BE PERFORMED DUE TO ERROR 235. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND SHOULD BE AWAKENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418698 ↗