ENDOPATH XCEL OPTIVIEW 2CB5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705036013730), received between Jul 30, 2019 and Nov 20, 2025 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Crack” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CONSULTANT INADVERTENTLY PERFORATED PART OF BOWEL WHICH WAS REQUIRED TO BE REPAIRED. PROCEDURE DELAYED BY 10 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23606573 ↗
• InjuryDec 4, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY, TROCAR SNAPPED IN HALF, LEAVING HALF IN THE FASCIA AND HALF IN THE ABDOMEN. MADE AN EXTRA INCISION TO RETRIEVE THE BROKEN TROCAR.

  Patient problems: Insufficient Information

  MAUDE report 20846529 ↗
• MalfunctionJul 10, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCARS WERE BENT AND BREAKING. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714604 ↗
• MalfunctionJul 10, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCARS WERE BENT AND BREAKING. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714546 ↗
• MalfunctionJul 10, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCARS WERE BENT AND BREAKING. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714299 ↗
• MalfunctionFeb 29, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SEAL WAS FAULTY, AUDIBLE LEAK. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808428 ↗
• MalfunctionFeb 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR VALVE WAS NOT WORKING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763862 ↗
• MalfunctionFeb 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE TOP KEPT COMING OFF OF THREE TROCARS WHEN PUTTING AND PULLING OUT THE INSTRUMENTS. THEY WERE ABLE TO COMPLETE THE CASE WITH THE DEVICES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639908 ↗
• MalfunctionFeb 23, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE SURGEON WAS REMOVING ALL DEVICES AND WHEN REMOVING THE LIVER RETRACTOR IT HIT THE TIP OF THE TROCAR AND BROKE A PIECE OFF WHICH FELL INTO THE PATIENT. ALL PIECES REMOVED FROM PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426570 ↗
• MalfunctionJan 6, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR BROKE DURING INSERTION INTO THE PORT SITE. SURGEON THOUGHT HE PUT TOO MUCH PRESSURE ON IT AS HE INSERTED IT. NO PATIENT INJURY AND NO FRAGMENTS WERE GENERATED. THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113336 ↗
• MalfunctionApr 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A CHOLECYSTECTOMY THE ETHICON XCEL 5MM TROCAR WAS "STICKING". THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013837 ↗
• MalfunctionMar 14, 2022Crack; Crack

  IT WAS REPORTED THE DOCTOR WAS FINISHING HIS SLEEVE GASTRECTOMY AND WAS REMOVING THE LIVER RETRACTOR FROM HIS TROCAR 5MM AND REALIZED THE TROCAR HAD BROKEN. SURGEON FISHED FOR THE PIECE THAT FELL INTO THE PATIENT, FOUND IT, AND REMOVED IT. THERE WAS A DELAY OF FIVE MINUTES TO THE PROCEDURE, SURGERY WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757696 ↗
• MalfunctionMar 14, 2022Crack; Crack

  IT WAS REPORTED THAT DOCTOR WAS PERFORMING A ROUX-EN-Y PROCEDURE. AT THE END ON HIS SURGERY, WHEN REMOVING THE LIVER RETRACTOR FROM TROCAR, 5MM, HE NOTICED THAT THE TIP OF THE TROCAR HAD BROKEN AND THE PIECE HAD FALLEN INTO THE PATIENT. HE HAD TO GO TO FISH FOR IT. HE FOUND IT AND REMOVED IT FROM THE PATIENT. SURGEON REPORTS HE DID NOTHING DIFFERENTLY THAN USUAL. SURGERY WAS DELAYED BY FIVE MINUTES BUT SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757440 ↗
• MalfunctionNov 16, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THE TROCAR CANNULA BROKE IN TWO PIECES WHEN INSERTING THE LIVER RETRACTOR. BOTH PIECES WERE EASILY RETRIEVED AND NO COMPLICATIONS TO PATIENT WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825095 ↗
• 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 9566652 ↗
• MalfunctionNov 29, 2019Break

  TROCAR BROKE IN HALF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9391779 ↗
• MalfunctionNov 8, 2019Break; Component Missing

  IT WAS REPORTED THAT DURING A LAP APPENDECTOMY, THE TROCAR WAS DAMAGED. AT THE VERY DISTAL END OF THE TROCAR, RIGHT AT THE END EFFECTOR, THERE IS A PIECE OF THE CLEAR CANNULA THAT WAS MISSING. IT IS UNKNOWN IF IT BROKE OFF OR WAS MANUFACTURED THIS WAY. THERE WAS NO PIECE FOUND. CASE COMPLETED WITH THE SAME TROCAR THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9299016 ↗
• MalfunctionJul 30, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SLEEVE OF THE TROCAR BROKE OFF WHILE INSERTION INTO THE PATIENT. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS IS ALL THE INFORMATION KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841240 ↗