ENDOPATH 5DCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10705036000785), received between Dec 11, 2017 and Jul 27, 2026 — classified as 4 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (17 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Arcing; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012843 ↗
• MalfunctionMay 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, COMPLAINED THAT THE SCISSOR TIP OF 5DCS WAS A BIT LOOSE WHEN THEY JUST STARTED USING IT. THEREFORE, THEY COULDN'T USE IT TO DISSECT THE TISSUE AND NEEDED TO OPEN ANOTHER ONE FOR THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264712 ↗
• MalfunctionApr 3, 2026Difficult to Open or Close; Noise, Audible

  IT WAS REPORTED THAT DURING A MYOMECTOMY, HE FOUND OUT THE 5DCS WAS HARDLY TO CLOSE AND OPEN, AND ALSO HAD SOME STRANGE SOUND DURING USING. THEREFORE, THEY CHANGE ANOTHER 5DCS FOR CASE USE. THERE WAS NO DELAY IN THE PROCEDURE AND WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779540 ↗
• MalfunctionFeb 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE ENDOSCOPIC SCISSORS COULD NOT ENABLE MONOPOLAR FEATURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260523 ↗
• MalfunctionJan 15, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN UNK PROCEDURE, THAT DEVICE WOULDN'T HEAT UP. NO PATIENT CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085782 ↗
• MalfunctionDec 11, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE UNK PROCEDURE, THEY NOTICED THAT THE RED PROTECTIVE COVERING ON THE SCISSORS¿ BLADE WAS BROKEN AND WAS HENCE CONCERNED ABOUT THE INTEGRITY OF THE PRODUCT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779129 ↗
• MalfunctionOct 21, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WAS A BUG INSIDE THE STERILE PACKAGE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346589 ↗
• MalfunctionOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCISSORS DON'T GET ELECTRIFIED. DURING THE OPERATION THE SCISSORS DID NOT RECEIVE AN ELECTRICAL IMPULSE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278912 ↗
• MalfunctionOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCISSORS DON'T GET ELECTRIFIED.DURING THE OPERATION THE SCISSORS DID NOT RECEIVE AN ELECTRICAL IMPULSE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278751 ↗
• MalfunctionOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE THE SCISSORS DON'T GET ELECTRIFIED. DURING THE OPERATION THE SCISSORS DID NOT RECEIVE AN ELECTRICAL IMPULSE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278733 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456861 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456859 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456858 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456856 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456854 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456843 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456821 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456819 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456818 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456817 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456815 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FACILITY RECEIVED BOXES OF PRODUCT FOR A TRIAL AND UPON USING THE PRODUCT THEY WOULD POP OPEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456813 ↗
• MalfunctionMay 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY AND WHEN ATTEMPTING TO TAKE TISSUE, THE SHELL WAS OPENED, MAINLY AT THE TOP, ABOVE THE TRIGGER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967614 ↗
• MalfunctionApr 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCISSOR TIP WENT THROUGH THE PLASTIC TIP PROTECTOR AND THEN THROUGH THE DRAPE IN THEIR DAVINCI PACK. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892444 ↗
• MalfunctionApr 17, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TIP WAS STIFF AND DIFFICULT TO CLOSE WHEN THE DEVICE WAS CHECKED AFTER THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED IN SURGERY. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857584 ↗