SERFAS Energy 0279251101Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327056884), received between Dec 21, 2018 and May 5, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Sparking

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, THE DEVICE SPARKED, TURNED BLACK, AND STOPPED CAUTERIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082725 ↗
• MalfunctionJan 9, 2026Material Fragmentation

  IT WAS REPORTED THAT THE WHITE PLASTIC TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS NOT LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021417 ↗
• MalfunctionJun 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP (CERAMIC PORTION) WAS BROKEN. THERE WAS NO REMAINING FRAGMENT IN THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180821 ↗
• MalfunctionFeb 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394228 ↗
• InjuryDec 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE WHEN THE ITEM WAS IN USE, THE WHITE SHEATH AT THE END CRACKED. WHEN THE EQUIPMENT WAS WITHDRAWN FROM THE WRIST JOINT, IT WAS NOTED THAT THE TIP (PLASTIC COLLAR) WAS MISSING. THE SURGEON WENT BACK INTO THE JOINT TO SEE IF HE COULD FIND THE TIP OF THE PROBE. THE SURGERY WAS COMPLETED; HOWEVER, THE TIP WAS NOT FOUND. THE SURGEON IS NOT SURE IF IT WAS STUCK BEHIND ANY TISSUE OR GOT SUCKED OUT WITH THE FLUID. THIS MAY REQUIRE MEDICAL INTERVENTION AT A LATER DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20871916 ↗
• MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BREAKING DURING THE PROCEDURE. THE DEVICE WAS ONLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864876 ↗
• MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BREAKING DURING THE PROCEDURE. THE DEVICE WAS ONLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864829 ↗
• InjuryOct 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF RF PROBE WAS BROKEN AND THAT IT IS POSSIBLE THAT BROKEN PIECE STILL EXIST IN THE PATIENT BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20477601 ↗
• InjuryJan 10, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PROCEDURE THE TIP OF THE AARDVARK BROKE OFF INSIDE A PATIENT. THE BROKEN PIECE WAS POTENTIALLY UNABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488792 ↗
• MalfunctionSep 8, 2022Fracture; Break; Fracture

  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 15379060 ↗
• InjuryMar 2, 2021Excessive Heating; Device Remains Activated; Excessive Heating

  IT WAS REPORTED THAT THE PATIENT WAS BURNED AND THE DEVICE WAS CONTINUOUSLY ACTIVATING.

  Patient problems: Burn, Thermal; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398501 ↗
• InjuryJan 25, 2021Device Remains Activated

  IT WAS REPORTED THAT THE PATIENT GOT BURNED, IN ADDITION TO THE MALFUNCTION OF CONTINUOUS ACTIVATION.

  Patient problems: Burn, Thermal; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11225116 ↗
• MalfunctionDec 9, 2020Melted; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSULATION ON THE DISTAL END OF THE DEVICE WAS MELTED/BURNED.

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

  MAUDE report 10979955 ↗
• MalfunctionOct 2, 2019Detachment of Device or Device Component; Material Deformation; Material Deformation

  IT WAS REPORTED THAT BLACK INSULATION CAME OFF OF THE DEVICE DURING THE PROCEDURE. ALL PIECES WERE REMOVED FROM THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9145854 ↗
• MalfunctionDec 21, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED CONTINUOUS ACTIVATION. IT WAS ALSO REPORTED THAT THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8190647 ↗