SILVERGLIDE 6720220015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540532305), received between Dec 7, 2018 and Jun 12, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE INSULATION WAS OBSERVED 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 22194381 ↗
• MalfunctionMay 9, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE, SMALL PARTICLES OF BLACK INSULATION MATERIAL FELL OF THE FORCEP TINES, LANDING ON THE SURGICAL DRAPE OF A MICROSCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997321 ↗
• MalfunctionAug 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE TIP WAS REPORTED TO HAVE BROKEN OFF THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A USE IN A PROCEDURE AT THE USER FACILITY. THE INITIAL REPORTER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17604747 ↗
• MalfunctionAug 29, 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 15310382 ↗
• MalfunctionJun 4, 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 11939441 ↗
• MalfunctionAug 31, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING CLEANING 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; No Patient Involvement

  MAUDE report 10471985 ↗
• MalfunctionMay 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE GUIDE STOP WAS FOUND TO BE DISASSEMBLED 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 Patient Involvement

  MAUDE report 8659401 ↗
• MalfunctionMay 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE GUIDE STOP WAS FOUND TO BE DISASSEMBLED 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 Patient Involvement

  MAUDE report 8659315 ↗
• MalfunctionMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE GUIDE STOP WAS FOUND TO BE DISASSEMBLED 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 Patient Involvement

  MAUDE report 8588332 ↗
• MalfunctionDec 21, 2018Material Fragmentation; Material Fragmentation

  THE DEVICE GUIDE STOP WAS FOUND TO BE DISASSEMBLED 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 Patient Involvement

  MAUDE report 8190990 ↗
• MalfunctionDec 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE TIP HAD FRACTURED OFF AND DISASSEMBLED, 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 Patient Involvement

  MAUDE report 8153719 ↗
• MalfunctionDec 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE GUIDESTOP WAS DISASSEMBLED 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 Patient Involvement

  MAUDE report 8143304 ↗