SilverGlide 6730220007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540695949), received between Jul 22, 2019 and Aug 22, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICE AT THE USER FACILITY, THE DEVICE TIPS WERE FOUND TO HAVE MATERIAL MISSING, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265337 ↗
• MalfunctionNov 24, 2021Flaked; Flaked

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY, PIECES OF INSULATION WERE FOUND TO BE MISSING FROM THE DEVICE BY THE MANUFACTURER SALES REPRESENTATIVE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869595 ↗
• MalfunctionJul 22, 2019Flaked; Flaked

  THE USER FACILITY REPORTED COATING COMING OFF THE DEVICE, POSING THE RISK OF MATERIAL BEING LOST IN A SURGICAL SITE, DURING PREPARATIONS BEFORE A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8811411 ↗