ENDOPATH XCEL B12XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705036001195), received between Jun 18, 2018 and Sep 1, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541817 ↗
• MalfunctionMar 2, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE, NOTED THE PACKING WAS DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488741 ↗
• MalfunctionFeb 6, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, DEFECTIVE PACKAGING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279020 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE USED ON THE PATIENT DURING AN UNK PROCEDURE, NOTED THE PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151993 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TITANIUM TIP WAS BROKEN DURING PROCEDURE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804485 ↗
• MalfunctionMay 19, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047222 ↗
• MalfunctionApr 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893441 ↗
• MalfunctionJan 7, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT IN THE COURSE OF A PROCEDURE USING THE PSEE60A, AN ERROR OCCURRED IN THE PROCESS OF FIRING. WHEN SURGEON PULLED BACK THE SAFETY LOCK AND FIRED THE TRIGGER, THE BLADE WAS SUDDENLY STOPPED IN THE MIDDLE OF CARTRIDGE. IT OCCURRED TWO MORE TIMES. AS AN EMERGENCY MEASURE, THE SURGEON BACKED OFF THE BLADE AND DETACHED IT FROM THE TISSUE. IT WAS FURTHER REPORTED THAT THE TROCAR HAD BEEN BENT WHEN IT WAS INSERTED INTO THE BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095289 ↗
• MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY FOR OBESITY, WHEN THE FORCEPS WAS INSERTED AND THE VALVE 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 20040377 ↗
• MalfunctionAug 6, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DEVICE WAS IN AND OUT OF THE TROCAR, THE DISTAL PART OF THE TROCAR WAS PARTIALLY CRACKED. STOPPED THE OPERATION IN TIME AND REMOVED THE FRAGMENT FROM THE BODY. REPLACED WITH A NEW TROCAR TO CONTINUE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924331 ↗
• MalfunctionJun 18, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DEVICE WAS IN AND OUT OF THE TROCAR, THE DISTAL PART OF THE TROCAR WAS PARTIALLY CRACKED. STOPPED THE OPERATION IN TIME AND REMOVED THE FRAGMENT FROM THE BODY. REPLACED WITH A NEW TROCAR TO CONTINUE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560623 ↗
• MalfunctionAug 24, 2023Crack; Crack

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN SURGERY, AFTER INSERTING INTO THE TROCAR, IT WAS NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612866 ↗
• MalfunctionMay 24, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR HAD A SMALL BROKEN PIECE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994059 ↗
• MalfunctionApr 27, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SPECIMEN WAS BEING RETRIEVED, THE BLACK/GREY SEAL DISPLACED FROM TROCAR AND FELL INTO CAVITY. TROCAR WAS REPLACED, LAPAROSCOPIC CAMERA WAS USED TO LOCATE SEAL AND REMOVE FROM PATIENT PRIOR TO END OF PROCEDURE. NO MODIFICATIONS TO PROCEDURE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823916 ↗
• MalfunctionFeb 14, 2022Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, A FOREIGN BODY WAS FOUND INSIDE THE PACKAGING (BLACK PARTICLE) AND A PERFORATION OF THE PACKAGING WAS ALSO NOTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529941 ↗
• MalfunctionFeb 1, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A LAP COLON PROCEDURE, AFTER INSERTING THE TROCAR, NOTED WAS BROKEN ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419859 ↗
• MalfunctionApr 21, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE SURGERY, THE PRODUCT WAS CHECKED FOR SAFETY USAGE AND THERE WAS NO PROBLEM, BUT AFTER THE TROCAR INSERTION, THE SURGEON LOOKED INTO THE SCOPE AND THE TIP WAS BENT. A NEW TROCAR WAS USED FOR THE SURGERY. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704584 ↗
• MalfunctionMay 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER INSERTING THE DEVICE INTO THE TROCAR, IT WAS NOTED THE DEVICE WAS BROKEN INTO A FEW PIECES. ALL PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. PATIENT CONSEQUENCE WAS NOT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10045793 ↗
• MalfunctionJun 18, 2018Break; Melted; Temperature Problem

  DURING ROBOTIC SURGERY, TROCAR USED FOR SCOPE IS BROKEN. THE REASON IS THAT WHEN THE TEMPERATURE RISES DUE TO THE LIGHT AND THE MATERIAL OF THE MELTED TROCARS IS PUT IN AND OUT OF THE APPARATUS, IT IS PRESUMED THAT A PHYSICAL BUMP HAS OCCURRED AND BROKEN, THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609517 ↗