Stryker 0703-046-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327466331), received between Aug 19, 2022 and Apr 16, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Output Problem

  IT WAS REPORTED THAT THE CUTTING (CUT) AND COAGULATION BUTTONS HAVE BEEN REVERSED. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894965 ↗
• MalfunctionApr 16, 2026Output Problem

  IT WAS REPORTED THAT THE CUTTING (CUT) AND COAGULATION BUTTONS HAVE BEEN REVERSED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24894959 ↗
• InjuryDec 17, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23829605 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Output Problem

  THE SURGICAL PENCIL WAS NOT WORKING WHEN ACTIVATED, ENTER CANNULA DETACHED OFF WHEN SURGEON ATTEMPTED TO ADJUST HAND PIECE.

  Patient problems: Insufficient Information

  MAUDE report 23062010 ↗
• MalfunctionJun 26, 2025Fire; Fire

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANTATION PROCEDURE AT THE USER FACILITY, A FLAME CAME OUT OF THE E-SEP PENCIL. NO INFORMATION WAS PROVIDED REGARDING ANY ADVERSE CONSEQUENCES, MEDICAL INTERVENTION, OR SURGICAL DELAY.

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

  MAUDE report 22337732 ↗
• MalfunctionMar 26, 2024Melted; Melted

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP ELECTRODE BLADE MELTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978431 ↗
• MalfunctionDec 21, 2023Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE COVIDIEN TIP DID NOT WORK IN THE E-SEP PENCIL, A REUSABLE EXTENDER (NOT STRYKER) WAS INSTERTED INTO THE PEN AND A COVIDIEN TIP WAS PLACED ONTO THAT. WHILE THIS ALLOWED THE PEN TO WORK, THE INSULATED SECTION OF THIS TIP THEN BURNED THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 18371840 ↗
• MalfunctionDec 21, 2023Sparking; Sparking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP PENCIL SPARKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371836 ↗
• MalfunctionOct 17, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHILE USING THE E-SEP PENCIL, THE PATIENTS TISSUE AROUND THE CUTTING AREA GETS VERY HOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS EVENT #1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949079 ↗
• MalfunctionOct 17, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHILE USING THE E-SEP PENCIL, THE PATIENTS TISSUE AROUND THE CUTTING AREA GETS VERY HOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS EVENT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949072 ↗
• MalfunctionAug 19, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, THE SURGEON USED THE E-SEP PENCIL TO CREATE A TEMPORARY BIPOLAR DEVICE. THE SURGEON BROUGHT IT OFF THE FIELD SHORTLY AFTER DOING THIS, AND CONSIDERED IT CHARRED. IT WAS ALSO REPORTED THAT THERE WAS A TWO MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259701 ↗