SILVERGLIDE 6715125012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540532152), received between Dec 4, 2018 and Feb 18, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2022Detachment 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 13563604 ↗
• MalfunctionApr 10, 2020Flaked; Flaked

  THE USER FACILITY REPORTED MATERIAL WAS FOUND TO BE MISSING FROM THE TIPS OF THE DEVICE DURING TESTING PRIOR TO A PROCEDURE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950005 ↗
• MalfunctionMar 20, 2020Flaked; Flaked

  THE USER FACILITY REPORTED MATERIAL WAS FOUND TO BE MISSING FROM THE TIPS OF THE DEVICE DURING TESTING PRIOR TO A PROCEDURE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9861901 ↗
• MalfunctionDec 4, 2018Material Fragmentation; Material Fragmentation

  THE DEVICE WAS REPORTED TO BE CHIPPED, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, FOUND DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8130529 ↗