ENDOPATH 23NBSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705036000402), received between Aug 23, 2018 and Apr 30, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Crack; Component or Accessory Incompatibility; Crack; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PEDIATRIC SURGERY, THE PORT WAS BROKEN AT THE BASE PART, AND THE OUTER SLEEVE WAS COME OFF. IT FELT LIKE THERE WAS A CAUGHT SLIGHTLY WHEN INSERTING THE INNER CYLINDER. 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 21935738 ↗
• MalfunctionFeb 12, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, A PLASTIC PIECE CAME OUT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PIECE FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367641 ↗
• MalfunctionJan 18, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY, IT WAS FOUND THAT THE TIP OF THE OUTER CYLINDER WAS DEFORMED WHEN IT WAS ABOUT TO BE INSERTED INTO THE PATIENT. THE DEVICE WAS TO BE USED ON THE OVIDUCT. 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 13280871 ↗
• MalfunctionSep 15, 2021Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TOTAL PROSTATECTOMY PROCEDURE, A FOREIGN MATTER LIKE "A PIECE OF THE VALVE WAS FOUND INSIDE THE PACKAGE DURING USE. IT WAS RETRIEVED FROM THE PATIENT." THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE. IT IS UNKNOWN WHY THE ISSUE OCCURRED. ANOTHER PACKAGE WAS OPENED TO COMPARE THE DEVICE WITH THE COMPLAINT DEVICE, THEN IT WAS FOUND THE PART OF THE VALVE WAS BROKEN. 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 12478833 ↗
• MalfunctionSep 15, 2021Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TOTAL PROSTATECTOMY PROCEDURE, A FOREIGN MATTER LIKE "A PIECE OF THE VALVE WAS FOUND INSIDE THE PACKAGE DURING USE. IT WAS RETRIEVED FROM THE PATIENT." THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE. IT IS UNKNOWN WHY THE ISSUE OCCURRED. ANOTHER PACKAGE WAS OPENED TO COMPARE THE DEVICE WITH THE COMPLAINT DEVICE, THEN IT WAS FOUND THE PART OF THE VALVE WAS BROKEN. 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 12478822 ↗
• MalfunctionAug 17, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE INSERTED 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 12334736 ↗
• MalfunctionJul 9, 2020Material Fragmentation

  IT WAS REPORTED THAT DURING A HERNIORRAPHY, THE SURGEON USED 2-3MM TROCAR AND NOTICED WHAT SEEMED TO BE SHARDS OF PLASTIC IN TROCAR. SURGEON PULLED THEM OUT AND SAVED THEM, AND THOUGH FRAGMENTS WERE GENERATED, THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251946 ↗
• MalfunctionNov 22, 2019Break; Device Fell

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UNKNOWN PROCEDURE, THE OUTER SEAL OF THE VALVE FELL OFF DURING USE. THE VALVE WAS BROKEN OUTSIDE THE PATIENT¿S BODY. 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 9362809 ↗
• MalfunctionNov 8, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UNKNOWN PROCEDURE, A FOREIGN PIECE LIKE A PART OF THE VALVE WAS FOUND ON THE SHAFT OF A FORCEPS WHEN THE FORCEPS WAS REMOVED FROM THE PATIENT THROUGH 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051304 ↗
• MalfunctionAug 23, 2018Contamination

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, A FOREIGN MATTER WAS FOUND DURING USE. IT WAS UNKNOWN WHETHER THE FOREIGN MATTER WAS A PART OF THE DEVICE, OR NOT. 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 7809949 ↗