NA 5407-300-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 545 adverse event reports that list this exact device (DI 07613327177350), received between Jul 24, 2018 and Jan 5, 2026 — classified as 545 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (460 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 25 most recent of 545 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE OF THE DEVICE WAS MISSING DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960564 ↗
• MalfunctionJun 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT A DRILL BIT BROKE OFF IN THE HANDPIECE DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326902 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SMALL PIECE FELL OUT OF THE DEVICE DURING A SURGICAL PROCEDURE. NO PATIENT IMPACT WAS REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185680 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BLACK WATERY SUBSTANCE CAME OUT OF THE DEVICE DURING A SURGICAL PROCEDURE. NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095811 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE USER FACILITY. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21944404 ↗
• MalfunctionApr 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN BUR WAS FOUND IN THE DEVICE AFTER A PROCEDURE AT THE USER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21790132 ↗
• MalfunctionApr 7, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE DEVICE PRODUCED METAL SHAVINGS DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21787069 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE DEVICE. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733781 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE DEVICE WAS NOTED TO HAVE MISSING GEARS. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905911 ↗
• MalfunctionOct 24, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A CAUTERY TIP BURNED HOLES IN DRAPES. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523527 ↗
• MalfunctionOct 18, 2024Fracture; Fracture

  IT WAS REPORTED THE DEVICE HAD A BROKEN BUR STUCK INSIDE DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480389 ↗
• MalfunctionSep 16, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT UPON INCOMING INSPECTION, A LARGE HOLE IN THE PACKAGING (PLASTIC) WAS NOTICED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230719 ↗
• MalfunctionSep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN EXTENDING THE TELESCOPIC END, THE PLASTIC CLIP FOR THE THIN SUCTION TUBING BROKE OFF. THEY COULD NOT LOCATE AT FIRST, BUT DID IN FACT LOCATE THE PIECE THAT BROKE OFF. THEY PLACED IN A RED BAG AND OPENED A NEW ONE WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125536 ↗
• MalfunctionJul 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE BOX WAS OPENED DURING TESTING, THE DEVICE LOOKED LIKE IT HAD BEEN USED/DIRTY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851934 ↗
• MalfunctionJul 19, 2024Fracture; Fracture

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A BUR PIECE STUCK IN IT WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780180 ↗
• MalfunctionMay 20, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP PENCIL ACTIVATED WITHOUT PUSHING THE BUTTON TO ACTIVATE IT. THE AREA WHERE THE SURGEON WAS USING THE PENCIL RESULTED IN A CUT THAT WAS UNINTENDED. THIS CAUSED THE INCISION TO BE JAGGED. THE SURGEON WAS ABLE TO RECTIFY THE AREA THAT WAS CUT UNINTENTIONALLY WHEN CLOSING THE INCISION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 19351155 ↗
• MalfunctionApr 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN BUR WAS IN THE MOTOR. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202953 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT A PART OF THE DEVICE FELL OUT DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934107 ↗
• MalfunctionFeb 28, 2024Fracture; Fracture

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THERE WAS A BROKEN BUR PIECE FOUND IN THE DRILL 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 18798519 ↗
• MalfunctionDec 15, 2023Material Disintegration; Detachment of Device or Device Component; Material Disintegration; Detachment of Device or Device Component

  IT WAS REPORTED THAT METAL WAS COMING OUT OF THE END DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340024 ↗
• MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS FULLY DISASSEMBLED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210501 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT A CERAMIC BALL WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133090 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE REAR END RING DISCONNECTED FROM THE PUSH ROD PRIOR TO OR AFTER A MEDICAL PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132914 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A SINGLE BUR FRAGMENT FOUND STUCK IN THE DRILL DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115755 ↗
• MalfunctionJun 15, 2023Fracture; Fracture

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE BUR BROKE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137434 ↗