SERFAS Energy 0279350201Recalls & reported problems
Stryker Corporation · Lateral Probe, Non-suction, Bendable, Max Cut Level 8 · 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 probe is a bendable tool used to cut and seal soft tissue during surgery such as ankle arthroscopy. Reports mostly describe the tip breaking off during procedures, with fragments later retrieved from the joint, and a report of no energy being delivered. There are 23 reports naming its identifier, with no deaths and 4 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
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327056914), received between Aug 16, 2018 and Mar 5, 2026 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Material Fragmentation3
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Failure to Deliver Energy1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information7
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient4
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Material Fragmentation
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE FOR THE REMOVAL OF A LESION IN THE ANKLE, A DEVICE (RADIOFREQUENCY) WITH THE ABILITY TO COAGULATE AND REMOVE SOFT TISSUE WAS USED. DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF (DETACHED FROM THE HANDPIECE) AND ENTERED THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENT WITHOUT CAUSING ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521410 ↗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 20870094 ↗MalfunctionFeb 26, 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 18784827 ↗MalfunctionOct 6, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890036 ↗MalfunctionDec 7, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15933496 ↗MalfunctionJul 15, 2022Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15029184 ↗MalfunctionJun 14, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14688856 ↗MalfunctionJan 24, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13334969 ↗MalfunctionJan 24, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13334968 ↗MalfunctionDec 7, 2021Contamination; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12957061 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12151209 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12151206 ↗InjuryJul 12, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND A PIECE REMAINED IN THE JOINT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12151198 ↗MalfunctionJun 22, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12040583 ↗MalfunctionMay 19, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11852158 ↗MalfunctionJan 21, 2021Break
THE DEVICE WAS RETURNED FOR INVESTIGATION AND IT WAS NOTICED THAT THE CERAMIC TIP WAS BROKEN. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11207552 ↗MalfunctionMar 4, 2020Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING AND HAD INSULATION DAMAGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9787353 ↗MalfunctionFeb 26, 2020Break; Break
IT WAS REPORTED THAT THE CERAMIC INSULATION BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9757210 ↗InjuryDec 17, 2019Break; Break
IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR THE CERAMIC TIP TO BE REMAINING IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9484471 ↗MalfunctionDec 9, 2019Break; Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9438570 ↗InjuryNov 14, 2019Break; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS LEFT INSIDE OF THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 9323349 ↗InjurySep 4, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO A PIECE STILL REMAINING INSIDE OF THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7844586 ↗MalfunctionAug 16, 2018Break
IT WAS REPORTED THAT THE TIPBROKE DURING A CASE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7789469 ↗
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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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