ENDOPATH XCEL OPTIVIEW 2CB12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705036014263), received between Nov 5, 2019 and Nov 26, 2025 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE THE SURGERY, CRACKS WERE NOTED ON THE SEAL. CHANGED THE NEW 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 23657615 ↗
• MalfunctionSep 8, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, NOTED THE DEVICE HAD CRACKS. ANOTHER ONE 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 22991238 ↗
• MalfunctionJul 3, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CANULA IS DETACHED AND THE GAS IS FILTERED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666365 ↗
• MalfunctionApr 24, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SIGMOIDECTOMY, THERE WAS AN AIR LEAKED WITHOUT INSERTING OR REMOVING FORCEPS. AFTER REPLACING ONLY THE HOUSING, THE AIR LEAKED STOPPED. 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 19175360 ↗
• MalfunctionApr 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CANNULA WAS DISASSEMBLED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092827 ↗
• MalfunctionMar 26, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE CANNULA DISARMED DURING SURGERY. PROCEDURE COMPLETED SUCCESSFULLY WITH 90 MIN DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977987 ↗
• MalfunctionMar 19, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, 12MM CANULA FAILURE, DISARMS DURING SURGERY. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932965 ↗
• MalfunctionMar 19, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, 12MM CANULA FAILURE, DISARMS DURING SURGERY. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932930 ↗
• MalfunctionApr 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE DEVICE WAS LEAKING TO THE SEAL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716111 ↗
• MalfunctionDec 6, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE END OF THE TROCAR BROKE IN THE PATIENT. TROCAR WAS RETRIEVED IT IN TWO COMPLETE PIECES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926062 ↗
• MalfunctionMay 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURES, THE TROCAR SLEEVE IS DISASSEMBLED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364325 ↗
• MalfunctionMar 1, 2022Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS SHIFTING AFTER INSERTING AND REMOVING DEVICES IN THE 2CB12LT. SURGEON HAD TO PUT FINGER IN TO OFFSET THE INNER SEAL IN ORDER TO FIT STAPLER IN TROCAR (NOT IDEAL AS ITS SUPPOSED TO BE A SMOOTH INSERT/REMOVAL PROCESS). TO BE NOTED IT WAS A LITTLE BETTER ONCE THE SURGEON HAD THE PATIENT HEAD UP MORE BUT STILL AN ISSUE. PRESSURE WAS SET TO TWELVE WHICH IS THE NORM FOR HIM. THERE WAS NO DELAY TO PROCEDURE AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13640545 ↗
• MalfunctionSep 14, 2020Material Separation; Gas/Air Leak; Material Separation; Gas/Air Leak

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY SURGERY, THE TROCAR LEAKED. WHEN CHECKED, IT COULD BE SEEN THAT IT WAS LOOSE AND SEPARATED INTO TWO PARTS. SURGERY WAS DELAYED BY TWENTY MINUTES HOWEVER NO FRAGMENTS WERE GENERATED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532727 ↗
• DeathJan 8, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAP CHOLE, A BLADELESS TROCAR WAS INSERTED ON AN UN-INSUFFLATED ABDOMEN AND BLEEDING WAS NOTICED. A LAPAROTOMY WAS PERFORMED AND THE BLEEDING WAS STOPPED. THEN THE PATIENT WAS IN RECOVERY AND WAS RUSHED BACK TO "THEATRE" (SURGERY). ANOTHER LAPAROTOMY WAS PERFORMED AND A BLEED WAS IDENTIFIED IN THE AORTA AT THE BI-FURCATION WITH THE ILIAC VESSELS. A VASCULAR SURGEON WAS CALLED, PATIENT WAS OPERATED ON FOR 11 HOURS, AND WAS TRANSFERRED TO HOSPITAL.

  Patient problems: Blood Loss; Death; No Code Available; Tissue Damage

  MAUDE report 9566554 ↗
• MalfunctionNov 5, 2019Mechanical Jam

  IT WAS REPORTED THAT DURING SET-UP FOR A LAP NEPHRECTOMY CASE AND PRIOR TO THE TROCAR BEING INSERTED INTO THE PATIENT, THE TROCAR WOULD NOT GO THROUGH THE SLEEVE. STAFF NOTICED THAT IT WAS JAMMED DUE TO THE INTERNAL SLEEVE ON THE TROCAR BEING BROKEN. A SECOND TROCAR WAS USED IN PLACE OF THE DAMAGED ONE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282271 ↗