SilverGlide 6730220012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540695956), received between Dec 22, 2020 and Dec 15, 2022 — classified as 7 malfunctions.

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

• MalfunctionDec 15, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING EVALUATION AT THE MANUFACTURER FACILITY, THE DEVICE TIPS WERE FOUND TO BE CHIPPED AND SILVER PLATING MATERIAL WAS MISSING, POSING THE RISK OF 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 15988885 ↗
• MalfunctionAug 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY, A PIECE OF THE DEVICE INSULATION WAS MISSING, 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 15190187 ↗
• MalfunctionDec 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING TESTING AT THE USER FACILITY BY THE MANUFACTURER SALES REPRESENTATIVE, IT WAS REPORTED A PIECE OF INSULATION WAS CHIPPED OFF 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 12956824 ↗
• MalfunctionOct 6, 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 TESTING BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586533 ↗
• MalfunctionOct 6, 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 TESTING BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586429 ↗
• MalfunctionDec 22, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING EVALUATION BY THE MANUFACTURER SALES REPRESENTATIVE IN THE STERILE PROCESSING DEPARTMENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11058078 ↗
• MalfunctionDec 22, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING EVALUATION BY A MANUFACTURER SALES REPRESENTATIVE IN THE STERILE PROCESSING DEPARTMENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11057883 ↗