ENDOPATH XCEL D5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705036001591), received between Aug 27, 2018 and Aug 6, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN REMOVING THE DEVICE FROM THE STORAGE CABINET, IT WAS FOUND THAT THE PACKAGING SEAL WAS OPEN DUE TO THE PACKAGING BEING DETACHED, MAKING IT IMPOSSIBLE TO USE THE ITEM DUE TO CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923898 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691909 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691902 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691894 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691887 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691875 ↗
• MalfunctionApr 18, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR SCREWS UP, MAKING IT IMPOSSIBLE TO USE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765154 ↗
• MalfunctionOct 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE HOSPITAL COMPLAINED THERE WAS NO CLEAR MARKING ON THE BOX TO INDICATE WHAT PRODUCTS WERE INSIDE, AND THE WRONG BOX WAS OPENED IN THEATRE. THIS PRODUCT WAS NOT USED IN CASE AND A NEW KIT WAS OPENED. THERE WAS NO HARM TO THE PATIENT AND APPROXIMATELY TWO MINUTES OF THEATRE TIME WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669519 ↗
• MalfunctionSep 9, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE DEVICE ARRIVED, THE STERILE PACKAGE WAS 'OPEN.' PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512410 ↗
• MalfunctionOct 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BUG WAS FOUND IN THE STERILE TROCAR PACKAGE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961490 ↗
• MalfunctionSep 25, 2018Dull, Blunt

  DURING SURGERY, THE DIALATING TROCAR KNIFE HAS NOT BEEN CAME OUT, PORT SITE INSERTION COULDN¿T BE PROCEED WITH BLUNT TIP OF TROCAR, SO SURGEON USED NEW TROCAR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907060 ↗
• MalfunctionAug 27, 2018Physical Resistance/Sticking

  WHEN SURGEON USED D5LT, THE KNIFE OF TROCAR WASN'T CAME OUT, SO IT WAS HARD TO IMPORT TROCAR TO ABDOMEN OF PATEINT. SO SURGEON DECIDED TO USE NEW ONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819951 ↗