ENDOPATH EPS07Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705036012511), received between Oct 19, 2018 and Feb 12, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT, DURING AN UNKNOWN SURGERY, THE TIP PART CAME OUT MORE THAN USUAL AND THE STOPPER DID NOT WORK. THIS EVENT WAS FOUND BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. AFFILIATE REFERENCE NUMBER: (B)(4). PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324541 ↗
• MalfunctionDec 4, 2025Suction Problem; Detachment of Device or Device Component; Suction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE COULD NOT SUCTION WHEN THE DEVICE WAS USED. THE TIP OF THE ELECTRIC SCALPEL ON THE SHAFT COULD NOT BE INSERTED OR REMOVED AND CAME OFF. THERE WAS NO EFFECT ON 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 23720576 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, IT WAS MORE DIFFICULT TO PULL IN AND OUT ELECTRODE THAN IN THE NORMAL CASE. WHEN STORING THE ELECTRODE, THE SHAFT MOVED AT ONCE AND THE ELECTRODE FELL OUT. 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 20041047 ↗
• MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE CAME OUT OF THE SUCTION HOLE IN 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 18817353 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE ELECTRODE 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 18258705 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE ELECTRODE CAME OUT FROM THE SHAFT DURING USE OF 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 18230454 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE ELECTRODE CAME OUT FROM THE HOLE ON THE SHAFT. 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 18073544 ↗
• MalfunctionJan 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC MYOMECTOMY, THE ELECTRODE WAS NOT FIXED ON THE SHAFT AND THE ELECTRODE COMES OFF 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 16146608 ↗
• MalfunctionMay 12, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PNEUMONECTOMY, THE DEVICE COULD NOT ENERGIZE PROPERLY AND DID NOT FUNCTION. 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 14378855 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THERE WAS AN UNUSUAL FEELING IN ROTATING TO CONNECT THE DEVICE WITH THE HANDLE DEVICE. WHEN THE HANDLE AND THE SHAFT WAS DISASSEMBLED, THE METALLIC PART OF THE SHAFT ROOT CAME OFF. 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 14074209 ↗
• MalfunctionSep 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE DEVICE BROKE DURING THE BLUNT DISSECTION. NO PIECES FELL INTO THE PATIENT. COMPETITIVE GENERATOR WAS USED. HOWEVER, THE ISSUE OCCURRED AT THE LATTER PART OF THE PROCEDURE, 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 12506222 ↗
• MalfunctionApr 5, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT, BEFORE A LAPAROSCOPIC HYSTERECTOMY, IT WAS FOUND THAT THE FOREIGN MATTER LIKE A WHITE POWDER WAS ON/AROUND THE ROTATE KNOB AFTER THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED FOR 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 11615143 ↗
• MalfunctionNov 16, 2020Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED DURING A LAPAROSCOPIC OB-GYN PROCEDURE, THE DEVICE BECAME NOT TO ACTIVATE AFTER THE DEVICE WAS USED FOR 10 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844385 ↗
• MalfunctionOct 19, 2020Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE DEVICE CANNOT BE ENERGIZED AFTER THE DEVICE WAS STARTED TO USE. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696704 ↗
• MalfunctionJan 16, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SHAFT WAS BROKEN OFF DURING 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 Consequences Or Impact To Patient

  MAUDE report 9599345 ↗
• MalfunctionOct 29, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC PROCEDURE, THE ELECTRODE TIP WAS BROKEN OUTSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED. NO PIECES FELL INTO THE PATIENT. OTHER COMPETITOR¿S DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017505 ↗
• MalfunctionOct 19, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, THE SHAFT AND THE ELECTRODE WERE BROKEN OFF. THE DEVICE WAS USED TO REMOVE A VERY BIG AND SOLID MYOMA. THE SHAFT WAS EXTREMELY LOADED. THE BROKEN PIECES WERE RETRIEVED AND NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985657 ↗