SERFAS Energy 0279351653Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327405828), received between Aug 21, 2018 and Mar 25, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Expiration Date Error

  IT WAS REPORTED THAT THERE WAS AN EXPIRED LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691307 ↗
• MalfunctionFeb 26, 2026Material Fragmentation

  IT WAS REPORTED THAT THE METAL FACE OF THE RF PROBE FELL OFF INSIDE THE PATIENT¿S JOINT DURING USE. ALL PIECES WERE RETRIEVED VIA X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458246 ↗
• MalfunctionFeb 14, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 21384583 ↗
• MalfunctionFeb 14, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 21384401 ↗
• MalfunctionFeb 14, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE DEVICE HAD INSUFFICIENT / NO ENERGY DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 21384400 ↗
• InjuryApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PARTS OF THE TIP WERE COMING OFF THE PROBE AND LEFT IN THE PATIENT. SOME PIECES OF DEBRIS WERE ABLE TO BE REMOVED USING SUCTION, HOWEVER SOME PIECES WERE LEFT IN PATIENT AS THEY WERE TOO DIFFICULT TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140554 ↗
• InjuryApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PARTS OF THE TIP WERE COMING OFF THE PROBE AND LEFT IN THE PATIENT. SOME PIECES OF DEBRIS WERE ABLE TO BE REMOVED USING SUCTION, HOWEVER SOME PIECES WERE LEFT IN PATIENT AS THEY WERE TOO DIFFICULT TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140213 ↗
• InjuryApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PARTS OF THE TIP WERE COMING OFF THE PROBE AND LEFT IN THE PATIENT. SOME PIECES OF DEBRIS WERE ABLE TO BE REMOVED USING SUCTION, HOWEVER SOME PIECES WERE LEFT IN PATIENT AS THEY WERE TOO DIFFICULT TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140195 ↗
• InjuryApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PARTS OF THE TIP WERE COMING OFF THE PROBE AND LEFT IN THE PATIENT. SOME PIECES OF DEBRIS WERE ABLE TO BE REMOVED USING SUCTION, HOWEVER SOME PIECES WERE LEFT IN PATIENT AS THEY WERE TOO DIFFICULT TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139890 ↗
• MalfunctionNov 11, 2022Break

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE AND WAS UNABLE TO BE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784655 ↗
• MalfunctionJun 29, 2021Continuous Firing; Continuous Firing; Self-Activation or Keying

  IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086362 ↗
• MalfunctionMay 6, 2021Break

  IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE PIECE WAS REMOVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783187 ↗
• MalfunctionMar 29, 2021Break; Material Integrity Problem; Material Integrity Problem

  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 11586115 ↗
• MalfunctionSep 4, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962655 ↗
• MalfunctionNov 19, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PROBE CHARRED THE TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Tissue Damage

  MAUDE report 8085538 ↗
• MalfunctionAug 21, 2018Arcing

  IT WAS REPORTED THAT THE PROBE ARCED. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802088 ↗