SonicOne O.R. E-SOGEN-ORRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841626100930), received between Jul 2, 2018 and Aug 17, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Human Factors Issue” (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.

• MalfunctionAug 17, 2021Pumping Problem; Temperature Problem; Pumping Problem; Temperature Problem

  UNIT WAS BEING USED DURING A DEBRIDEMENT CASE IN THE OPERATION ROOM. OPERATION ROOM . STAFF EXPERIENCED DIFFICULTY GETTING THE PROPER IRRIGATION FLOW. RN NOTICED THE VENT WAS CLOSED ON THE BAG SPIKE PART OF THE MXB-T TUBING SET. RN OPENED THIS VENT AND FLOW INCREASED, BUT THE HANDPIECE STILL INCREASED IN TEMPERATURE TO THE POINT WHERE IT WAS NOTICEABLE TO THE SURGEON. HEAT WAS ENOUGH TO CAUSE A BURN TO THE PATIENT. THE ORIGINAL HANDPIECE WAS USED WITH ANOTHER GENERATOR TO FINISH THE CASE.

  Patient problems: Impaired Healing

  MAUDE report 12331559 ↗
• InjuryJul 2, 2018Use of Incorrect Control/Treatment Settings; Human Factors Issue; Use of Incorrect Control/Treatment Settings; Human Factors Issue

  THE CUSTOMER STATED PROBLEM, "INADEQUATE WATER FLOW FROM HAND PIECE RESULTING IN THERMAL INJURY TO WOUND BED."

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7656004 ↗