ENDOPATH EPH04Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705036001874), received between Aug 25, 2020 and Sep 5, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978507 ↗
• MalfunctionMay 22, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS POOR CONNECTION. NOT WORKING. NO PATIENT CONSEQUENCES REPORTED WHEN THIS COMPLAINT EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070723 ↗
• MalfunctionMar 31, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS ENERGIZED EVEN THOUGH THE BUTTON WAS NOT 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 21733795 ↗
• MalfunctionApr 8, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE CONNECTION CONDITION WAS CONNECTED FOR ALL THE TIME, AFTER THE DEVICE WAS CONNECTED. 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 19060051 ↗
• MalfunctionJan 17, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE ¿THE ADHESIVE ON THE BOX SEPARATED SO THEREFORE IT IS NO LONGER STERILE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184221 ↗
• InjuryJan 13, 2023Difficult or Delayed Activation; Connection Problem; Insufficient Device Problem Information; Difficult or Delayed Activation; Connection Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE SURGEON FELT LIKE THE DEVICE DOES NOT ALLOW HER TO EASILY TRANSECT WHAT SHE NEEDS TO GAIN ACCESS TO CRITICAL STRUCTURES DUE TO HER NOT BEING ABLE TO EASILY ROTATE THE SHAFT, THE SHAFT IS HARD TO RETRACT, AND THE CORDS CREATING A DRAG MAKING THE WHOLE DEVICE HARD TO MANIPULATE. DUE TO THIS, SHE FELT LIKE SHE WAS NOT ABLE TO ACCOMPLISH WHAT SHE NEEDED TO LAPAROSCOPICALLY AND CONVERTED THE PROCEDURE TO OPEN. THERE WERE DIFFICULTIES AND THE SURGERY WAS DELAYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16162700 ↗
• MalfunctionSep 30, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE SUCTIONED ALTHOUGH THE BUTTON WAS NOT PRESSED WHEN THE DEVICE WAS SET. 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 15510601 ↗
• MalfunctionJan 5, 2021Inability to Irrigate; Difficult or Delayed Activation; Material Integrity Problem; Inability to Irrigate; Difficult or Delayed Activation; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE EPH04 DIDN´T CLOSE THE VALVE AND ASPIRATE CONTINUOUSLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118578 ↗
• MalfunctionNov 5, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE EPH04 STARTED TO SUCK UNEXPECTEDLY WITHOUT ACTIVATION. THERE WERE NO PATIENT CONSEQUENCES.

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

  MAUDE report 10792113 ↗
• MalfunctionAug 25, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SUCTION WAS ACTIVATED WITHOUT PRESSING BUTTON. IT IS UNKNOWN IF THE PATIENT HAD ANY CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448729 ↗