SILVERGLIDE 6710190010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540714855), received between Dec 14, 2020 and Sep 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Flaked” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING OF THE DEVICE AT THE USER FACILITY, SILVER PLATING MATERIAL WAS FOUND TO BE MISSING FROM THE DEVICE TIPS, 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 17783220 ↗
• MalfunctionAug 24, 2023Flaked; Flaked

  THE USER FACILITY REPORTED MATERIAL WAS MISSING FROM THE DEVICE TIPS, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE. THERE WAS NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION, NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619210 ↗
• MalfunctionAug 24, 2023Flaked; Flaked

  THE USER FACILITY REPORTED MATERIAL WAS MISSING FROM THE DEVICE TIPS, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE. THERE WAS NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION, NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619207 ↗
• MalfunctionFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE TIP WAS FOUND TO BE FRACTURED OFF AND MISSING FROM THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366938 ↗
• MalfunctionDec 14, 2020Flaked; Flaked

  THE DEVICE TIPS WERE REPORTED TO BE CHIPPED, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A TESTING AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002353 ↗