SERFAS Energy 0279351400Recalls & reported problems
Stryker Corporation · 90-S Accelerator, Suction Probe, Non-bendable, Max Cut Level 11 · Class 2
All models of SERFAS Energy (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker SERFAS Energy accelerator is a hand-held electrosurgical cutting and coagulation probe used in surgery. The 66 reports mostly describe the probe firing continuously or on its own, failing to deliver energy, sparking, overheating, and pieces breaking off in the patient; a few mention burns. There are no deaths and 5 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
- 67
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 07613327057041), received between Jun 14, 2018 and Sep 24, 2026 — classified as 5 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Continuous Firing” (24 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Continuous Firing24
- Failure to Deliver Energy9
- Material Fragmentation6
- Device Remains Activated5
- Sparking5
- Self-Activation or Keying4
- Device Operates Differently Than Expected3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Known Impact Or Consequence To Patient11
- Insufficient Information10
- Burn(s)4
- Foreign Body In Patient3
- Shock2
- Superficial (First Degree) Burn2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892236 ↗MalfunctionJun 17, 2026Overheating of Device
IT WAS REPORTED THAT THE DEVICE REPORTEDLY OVERHEATED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540866 ↗MalfunctionApr 20, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE DEVICE WAS IN STERILIZED PACKAGING, BUT THERE WERE IMPURITIES LIKE METAL INSIDE THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932776 ↗MalfunctionAug 27, 2025Sparking; Sparking
IT WAS REPORTED THAT THERE WAS SPARK AND POOR OPERATION AND FAULTY BUTTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22907619 ↗MalfunctionJan 30, 2025Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277216 ↗MalfunctionJan 30, 2025Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277212 ↗MalfunctionJan 6, 2025Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079447 ↗MalfunctionDec 23, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000618 ↗MalfunctionDec 19, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20981543 ↗MalfunctionDec 19, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20981386 ↗MalfunctionDec 6, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20869625 ↗MalfunctionNov 1, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20592078 ↗MalfunctionOct 23, 2024Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516450 ↗MalfunctionOct 22, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20509667 ↗MalfunctionOct 15, 2024Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457458 ↗MalfunctionSep 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20197021 ↗MalfunctionSep 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20195879 ↗MalfunctionAug 9, 2024Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19956614 ↗InjuryAug 9, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE PROCEDURE THE METAL SHEET AT THE HEAD WAS MISSING. THE BEDSIDE FLUOROSCOPY RESULT SHOWED THAT NO FOREIGN OBJECTS WERE FOUND. THE TRAVELING NURSE FILTERED THE WASHING SOLUTION DURING THE SURGERY AND DID NOT FIND ANY MISSING SHEETS. THE LOST FRAGMENTS WERE NOT FOUND AND IT IS UNCERTAIN WHETHER IT IS IN THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 19956566 ↗MalfunctionAug 8, 2024Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945459 ↗MalfunctionAug 8, 2024Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945350 ↗MalfunctionDec 18, 2023Electrical Shorting; Electrical Shorting
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 18352565 ↗MalfunctionDec 18, 2023Electrical Shorting; Output Problem; Electrical Shorting; Output Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347384 ↗MalfunctionDec 12, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING PROCEDURE MATERIAL DETACHED FROM THE PROBE. THE PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18315365 ↗MalfunctionDec 12, 2023Continuous Firing; Continuous Firing
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314445 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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