SILVERGLIDE 6720240012Recalls & reported problems
Stryker Corporation · Non-Stick Bipolar Electrosurgical Precision Forceps Bayonet · Class 2
All models of SILVERGLIDE (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
The Stryker Silverglide non-stick bipolar electrosurgical forceps is a surgical instrument used to cut and coagulate tissue. All 24 reports are malfunctions describing the instrument's tip breaking or chipping off, or insulation flaking, with the concern that small pieces could be lost inside a surgical site. There are no reported deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540532336), received between Dec 18, 2018 and Jul 17, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component17
- Flaked7
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Patient Involvement8
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED ONE OF THE TIPS OF THE DEVICE WAS OBSERVED TO BE FRACTURED OFF AND MISSING 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 22529750 ↗MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED ONE OF THE TIPS OF THE DEVICE WAS OBSERVED TO BE FRACTURED OFF AND MISSING 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 22283855 ↗MalfunctionJan 9, 2025Flaked; Flaked
THE MANUFACTURER SERVICE TECHNICIAN REPORTED PIECES OF INSULATION WERE CHIPPED OFF THE TIP OF THE DEVICE, 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 21117906 ↗MalfunctionJan 8, 2025Flaked; Flaked
THE MANUFACTURER SERVICE TECHNICIAN REPORTED PIECES OF INSULATION WERE CHIPPED OFF THE TIP OF THE DEVICE, 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 21106507 ↗MalfunctionNov 25, 2024Detachment 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 PROCEDURE AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20776102 ↗MalfunctionNov 25, 2024Detachment 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 PROCEDURE AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20775308 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED ONE OF THE TIPS OF THE DEVICE WAS OBSERVED TO BE FRACTURED OFF AND MISSING 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 20642340 ↗MalfunctionMar 20, 2024Flaked; Flaked
IT WAS REPORTED THAT DURING STERILE PROCESSING OF THE DEVICE AT THE USER FACILITY, THE DEVICE TIP WAS 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 18944467 ↗MalfunctionDec 6, 2023Flaked; Flaked
IT WAS REPORTED THAT DURING TESTING OF THE DEVICE AT THE USER 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 18274458 ↗MalfunctionMay 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IN STERILE PROCESSING AT THE USER FACILITY, IT WAS REPORTED THE DEVICE GUIDE STOP WAS 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 16898788 ↗MalfunctionApr 20, 2023Detachment 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16781163 ↗MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IN STERILE PROCESSING AT THE USER FACILITY, IT WAS REPORTED THE DEVICE GUIDE STOP PIN BROKE OFF THE DEVICE DURING DECONTAMINATION, 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 14113575 ↗MalfunctionFeb 7, 2022Flaked; Flaked
IT WAS REPORTED THAT DURING TESTING OF THE DEVICE AT THE USER FACILITY, THE DEVICE TIPS WERE FOUND TO HAVE 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 13471133 ↗MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IN STERILE PROCESSING AT THE USER FACILITY, IT WAS REPORTED THE DEVICE GUIDE STOP SCREW WAS 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 11647987 ↗MalfunctionDec 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE GUIDE STOP WAS FOUND TO BE FRACTURED 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 11032153 ↗MalfunctionMar 17, 2020Flaked; Flaked
IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, INSULATION WAS FOUND TO BE CHIPPING OFF 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 9842730 ↗MalfunctionMar 17, 2020Flaked; Flaked
IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, INSULATION WAS FOUND TO BE CHIPPING OFF 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 9842681 ↗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 8659314 ↗MalfunctionMay 28, 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 8646439 ↗MalfunctionApr 19, 2019Detachment 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. THE DEVICE WAS FOUND IN A REPAIR BIN AT THE USER FACILITY BY A MANUFACTURER SALES REPRESENTATIVE. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Information
MAUDE report 8532866 ↗MalfunctionMar 22, 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 8444590 ↗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 8444457 ↗MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE INSULATION WAS FOUND TO BE PEELING OFF OF THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, 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 8175148 ↗MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE INSULATION WAS FOUND TO BE PEELING OFF OF THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, 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 8175147 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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