ENDOPATH EPS01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705036012450), received between Mar 29, 2018 and Dec 9, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE INTERNAL TUBE (HOOK) AND THE EXTERIOR TUBE (THE PLASTIC TUBE AT THE OUTERMOST) WAS DETACHED. THE SURGEON CHANGED ANOTHER ONE AND CONTINUE THE SURGERY SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877974 ↗
• MalfunctionNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, BEFORE AN UNKNOWN SURGERY, A COMPONENT CAME OFF AND IT WAS HANDLED BY A REPLACEMENT. NO EFFECT ON THE PATIENT. IT OCCURRED BEFORE THE START OF THE SURGERY. 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 20589178 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, WHEN OPEN THE PACKAGE, IT WAS FOUND THAT THE TIP OF THE SHAFT WAS BROKEN. 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 20384521 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN WHEN THE DEVICE WAS UNPACKED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20227988 ↗
• 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 UNKNOWN SURGERY, WHILE THE DEVICE WAS USED AS USUAL, THE OUTER CYLINDER AND INNER CYLINDER OF THE SHAFT CAME OFF. NO PIECES WERE LEFT IN THE PATIENT. THE SAME CASE HAD HAPPENED FREQUENTLY. 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 19606190 ↗
• MalfunctionMay 7, 2024Detachment 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. 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 19260048 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING USE, THE METAL HOOK TIP FALL FROM THE SUCTION AND CANNOT BE USED ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545950 ↗
• MalfunctionDec 7, 2023Detachment 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 UNKNOWN PROCEDURE IN OB-GYN, THE CONNECTION PART OF THE DEVICE WAS BROKEN, AND THE ELECTRODE EXPOSED WHEN TRIED TO PUT OUT ELECTRODE OF EPS01. NO PIECES 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 18284522 ↗
• MalfunctionAug 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, A PIECE OF METAL WAS FOUND OUTSIDE THE PATIENT, AND THERE IS A POSSIBILITY THAT SOME PART OF THE DEVICE FELL OFF. NO PIECES FELL INTO THE PATIENT. THE DEVICE WAS USED ON LIGAMENT. THE 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 17492368 ↗
• MalfunctionJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISTAL TIP OF BLADE WAS BROKEN OUT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159947 ↗
• MalfunctionOct 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC PROCEDURE, THE ELECTRODE AND THE SHAFT CAME APART DURING USE. NO PIECES 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 15700965 ↗
• MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, A PIECE OF WHAT LOOKED LIKE THE TIP OF THE DEVICE FELL OFF DURING USE. THE PIECE HAS BEEN RETRIEVED. 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 15671473 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A OB-GYN PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN. NO PIECES 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 15404987 ↗
• MalfunctionAug 29, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE DID NOT ENERGIZE PROPERLY DURING USE. THE DEVICE SOMETIMES DID NOT FUNCTION WHEN THE CUT BUTTON WAS PRESSED. THE DEVICE WAS USED ON THE ADIPOSE TISSUE AND MEMBRANE. 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 15314817 ↗
• MalfunctionAug 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE EPS01 TIP WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252298 ↗
• MalfunctionAug 18, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC OB-GYN PROCEDURE, THE DEVICE DID NOT FUNCTION UNDER THE COAGULATION MODE OR THE CUT MODE WHEN THE DEVICE WAS ENERGIZED. 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 15249562 ↗
• MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP BROKE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955879 ↗
• MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HOOK TIP WAS BROKEN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955831 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE ELECTRODE WAS BROKEN. THE DEVICE WAS NOT USED FOR THE PATIENT. NO PIECES 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 14744841 ↗
• MalfunctionMar 31, 2022Inability to Irrigate; Arcing of Electrodes; Inability to Irrigate; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE BECAME NOT TO ENERGIZE SUDDENLY, AND BECAME NOT TO IRRIGATE. 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 13969000 ↗
• MalfunctionAug 20, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT ENERGIZE PROPERLY. 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 12350515 ↗
• MalfunctionAug 4, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE COULD CUT BUT COULD NOT COAGULATE. THE DEVICE WAS USED ON THE BLOOD VESSELS. 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 12278520 ↗
• MalfunctionApr 23, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE DID NOT CUT FROM THE BEGINNING. THE ACTIVATION SOUND WAS HEARD BUT THE DEVICE DIDN'T ACTIVATE. THE GENERATOR WAS REPLACED BUT IT WAS UNABLE TO ENERGIZE THE DEVICE. 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 11718878 ↗
• MalfunctionNov 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON TRIED TO USE THE TIP OF EPS01, THE TIP WAS BROKEN DURING THE SURGERY. A NURSE CHANGED IT TO THE NEW ONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10867811 ↗
• MalfunctionApr 27, 2020Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE KEPT ACTIVATING WHEN USED FOR COAGULATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001583 ↗