VersaPulse PowerSuite VersaPulse PowerSuite 100W (REF RG0638-803-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109145860), received between Dec 21, 2022 and Feb 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 18, 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.

• MalfunctionFeb 28, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE ENTERED CASE SAVER MODE DURING THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453006 ↗
• MalfunctionDec 21, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE, THE PHYSICIAN FOUND THAT THE DEBRIS SHIELD WAS DAMAGED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR A CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028844 ↗