SilverGlide 6730240012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540696069), received between Jan 11, 2019 and Sep 27, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY INSULATION WAS MISSING NEAR THE TIP OF ONE TINE OF THE DEVICE, 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 17830358 ↗
• MalfunctionAug 16, 2022Flaked; Flaked

  IT WAS REPORTED THAT IN THE STERILE PROCESSING OF THE DEVICE AT THE USER FACILITY, THE DEVICE TIPS WERE FOUND TO BE WORN AND CHIPPED, WITH SILVER PLATING 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 15237012 ↗
• MalfunctionJul 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT OF THE USER FACILITY, A PIECE OF INSULATION WAS FOUND TO BE MISSING FROM THE DEVICE, 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 14981940 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY INSULATION WAS MISSING NEAR THE TIPS OF THE DEVICE, 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 Patient Involvement

  MAUDE report 8446115 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY INSULATION WAS MISSING NEAR THE TIPS OF THE DEVICE, 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 Patient Involvement

  MAUDE report 8446110 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY INSULATION WAS MISSING NEAR THE TIPS OF THE DEVICE, 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 Patient Involvement

  MAUDE report 8444458 ↗
• MalfunctionJan 11, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: No Patient Involvement

  MAUDE report 8241212 ↗