GoldVac 60-7570-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405061199), received between Mar 24, 2016 and Mar 24, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Protective Measures 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2016Self-Activation or Keying; Protective Measures Problem

  DURING USE OF A GOLDVAC PUSH BUTTON ELECTROSURGICAL PENCIL WITH 15 FOOT CORD IN A SUBTOTAL ABDOMINAL HYSTERECTOMY, THE GOLDVAC PENCIL WAS REPORTED TO SELF-ACTIVATE IN THE SAFETY HOLSTER AT LEAST TWELVE (12) TIMES. IT WAS REPORTED THAT BY JUST BRUSHING AGAINST THE SIDE OF THE SAFETY HOLSTER ACTIVATED THE PENCIL. THE END-USER STATES THAT THEY BELIEVE THE ACTIVATIONS ARE FROM THE PENCIL BEING PINCHED IN THE SAFETY HOLSTER. THERE IS MINIMAL RISK FOR INJURY WITH THE PENCIL ACTIVATING WITHIN THE SAFETY HOLSTER. AS REPORTED, THERE WAS NO USER OR PATIENT INJURY REPORTED WITH THIS REPORTED PROBLEM. THIS REPORT IS BEING SUBMITTED DUE TO POTENTIAL FOR USER/PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5524223 ↗