ENDOPATH EPS03Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10705036012474), received between Feb 13, 2018 and Sep 2, 2026 — classified as 1 injury, 108 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (77 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569742 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411803 ↗
• InjuryAug 14, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50255335 ↗
• MalfunctionJul 31, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100963 ↗
• MalfunctionJul 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25877644 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP BROKE OFF DURING USE. NO DELAY IN PROCEDURE. THERE WERE NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679180 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, AN UNKNOWN FRAGMENT FELL FROM THE TIP OF THE PROBE SHAFT ON SURGICAL FIELD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469942 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN OB-OYN SURGERY, THERE WAS A PROBLEM WITH THE INNER CYLINDER. THE ELECTRODE PART HAS COME OFF FROM THE INNER CYLINDER. THIS EVENT WAS FOUND BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379950 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP ANTERIOR RESECTION THE HOOK COMPONENT OF THE PROBE PLUS LOOSENED AND DETACHED FROM THE SHAFT. AFTER THE SURGEON TRIED TO ATTACH IT BACK TOGETHER, THE CONNECTION REMAINED LOOSE. HE HAD TO OPEN ANOTHER SET IN ORDER TO COMPLETE THE SURGERY. NO PARTS WERE CREATED OR LEFT INSIDE THE PATIENTS CAVITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619748 ↗
• MalfunctionNov 6, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED BY THE SALES REP THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE COULD CUT BUT COULD NOT COAGULATE AT THE END OF THE OPERATION. THE DEVICE WAS ABLE TO BE USED AGAIN AND IT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486192 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ELECTRODE AND THE TUBE PART BROKE COMPLETELY IN THE MIDDLE OF THE PROCEDURE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903724 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC OVARIAN CYSTECTOMY, AROUND THE END OF THE PROCEDURE, IT WAS FOUND THAT THERE WAS A BREAKAGE TO THE TIP OF ESP03. THE MOST PART OF THE BREAKAGE WAS FOUND SINCE IT WAS ATTACHED TO SURGICAL DRAPE. HOWEVER, IT WAS DIFFICULT TO THINK THAT ALL THE PIECES WERE COLLECTED, AND THEY WEREN¿T COLLECTED OTHER OUTSIDE OF THE BODY, SO THE HOSPITAL WASHED AND SUCKED INSIDE OF THE ABDOMINAL CAVITY CAREFULLY. IT WAS STILL UNKNOWN WHETHER OTHER SMALL PIECES COULD BE COLLECTED OR NOT. THE THING THAT COULD BE RECEIVED WAS ONLY A SHAFT, NOT AN EPH HANDLE. THE PIECES WHICH COULD BE COLLECTED WERE ALSO RECEIVED. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750119 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN IN USE OF THE DEVICE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737663 ↗
• MalfunctionJul 17, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING OB-GYN PROCEDURE, SEALING COULD BE DONE BY USING THE DEVICE, BUT IT DID NOT HAVE ANY RESPONSES ALTHOUGH CUTTING WAS PRESSED. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530819 ↗
• MalfunctionJun 13, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS ACTIVATED, BUT THE TISSUE COULD NOT BE CUT OFF BECAUSE THE SHARPNESS OF THE DEVICE WAS DULL. BY KEEPING THE GENERATOR AND REPLACING THE CORD AND THE TIP, IT COULD BE CUT AS USUAL. THE DOCTOR REPORTED THAT THERE WAS AN ABSOLUTE DIFFERENCE IN CUTTING. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202707 ↗
• MalfunctionMay 21, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING THE LAPAROSCOPIC OB-GYN SURGERY, THE DEVICE DID NOT SEAL THE TARGET TISSUE. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060279 ↗
• MalfunctionApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC PROCEDURE, METAL PART AT THE BASE OF THE DEVICE CAME OFF EASILY, AND IT SEEMED THAT THE DEVICE OF THE GLUE PEELED OFF. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912649 ↗
• MalfunctionApr 25, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE CUT AND COAGULATION BUTTON WAS PRESSED, THE DEVICE ENERGIZED SLOWLY, AND THE OUTPUT WAS WEAK (THE OUTPUT OF THE GENERATOR WAS 40). NO PIECES WERE FELL INTO THE PATIENT. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908611 ↗
• MalfunctionApr 23, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING THE LAPAROSCOPIC PROCEDURE, AFTER OPENING THE DEVICE, IT DID NOT POWER UP PROPERLY. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894494 ↗
• MalfunctionNov 18, 2024Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE DEVICE WAS USED IN THE BEGINNING, BUT THE DEVICE BECAME UNABLE TO COAGULATE, THE DEVICE DID NOT RESPOND. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708920 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY: TLH, THE ELECTRODE COULD NOT BE PULL IN AND OUT SMOOTHLY. SO, WHEN CHECKED THE TIP, IT WAS CONFIRMED THE BREAKAGE. IT WAS SUSPECTED THAT PROBABLY BECAUSE THE TIP WAS PUT IN AND OUT EVEN IT WAS STILL HEAT. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20336945 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, BEFORE USING THE DEVICE, THE INNER CYLINDER OF THE SHAFT, THE WHOLE ELECTRODE, CAME OFF. SO, THE DEVICE COULD NOT BE USED. THE OUTER CYLINDER OF THE SHAFT TOTALLY CAME OFF FROM THE INNER CYLINDER OF THE ELECTRODE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206333 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING OB-GYN PROCEDURE, THE TIP OF THE DEVICE CAME OFF WHEN THE DEVICE WAS ASSEMBLED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805407 ↗
• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, THE FUNDAMENTAL PART OF THE DEVICE CAME OFF WHEN OPENING AND CLOSING THE SHAFT DURING USE. THE DEVICE WAS USED ON A UTERUS. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722800 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, CONNECTING EPH02 TO EPS03 AND THE DEVICE WAS USED. THE HOOK BECAME NOT ROTATING SO THE DOCTOR CHECKED, AND IT WAS FOUND THAT OUTER CYLINDER AND INNER OF THE MAIN BODY CAME OFF. NO PIECES WERE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE DEVICE WAS USED ON UTERUS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606061 ↗