ENDOPATH XCEL OPTIVIEW 2B5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705036013709), received between Jan 23, 2017 and Jul 6, 2026 — classified as 2 deaths, 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Crack” (21 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, MOISTURE INSIDE STERILE PACKAGING - NOTICED ON TABLE SET UP PRE-OP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716349 ↗
• MalfunctionMay 14, 2026Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE SURGEON NOTED THE DEVICE WITH AIR LEAKAGE ISSUE. 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 25176340 ↗
• MalfunctionApr 6, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE NURSE FOUND THAT THERE WAS THE HOLE ON THE PACKAGE OF THE PRODUCT. SO THEY DIDN'T USE THIS PRODUCT. NO PATIENT INVOLVEMNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794011 ↗
• 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 23606406 ↗
• MalfunctionApr 30, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC OB-GYN SURGERY, THE DEVICE WAS BROKEN DURING USE AS THE UMBILICAL REGION PORT. IT WAS NORMAL USE, AND DID NOT APPLY EXCESSIVE PRESSURE. 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 21935837 ↗
• MalfunctionApr 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21903139 ↗
• MalfunctionSep 18, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHILE ATTEMPTING TO INSERT THE TROCAR IT BENT. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251499 ↗
• MalfunctionSep 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TIP OF THE OUTER CYLINDER WAS PARTIALLY MISSING AND DAMAGED. 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 20197117 ↗
• MalfunctionAug 27, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A ROBOTIC SLEEVE GASTRECTOMY PROCEDURE, THAT WHILE ADVANCING THE TROCAR FROM THE PERITONEUM DEEPER IN THE ABDOMEN WHEN IT SNAPPED IN HALF. ALL FRAGMENTS WERE RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076315 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN ROBOTIC CASE, THE OBTURATOR OF THE TROCAR BROKE. NO FURTHER DETAILS WERE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037518 ↗
• 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 19714706 ↗
• MalfunctionApr 23, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR BROKE. RETRIEVED THE BROKEN OFF PIECE AND THE CASE WAS COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164341 ↗
• MalfunctionApr 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LAP GASTRECTOMY SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087539 ↗
• MalfunctionJan 3, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE, SLEEVE TROCAR WAS INSERTED TO OBESE WOMAN. DOCTOR USED EXCESSIVE FORCE ON THE ABDOMINAL WALL. IN RESULTS, THE TROCAR SLEEVE WAS BROKEN. THERE WAS NO DAMAGE OR SUBSTANTIAL DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435855 ↗
• MalfunctionNov 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED GASTRIC SLEEVE, WHEN INSERTING THE 5MM OBTURATOR TO GAIN ACCESS FOR THE LIVER RETRACTOR IN THE SUB XIPHOID, A SNAP WAS FELT AND IT WAS DISCOVERED THAT THE OBTURATOR WAS CRACKED IN HALF. THIS WAS JUST WITH THE OBTURATOR NOT WITH THE STABILITY SLEEVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192123 ↗
• MalfunctionOct 3, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN REMOVING THE LAPAROSCOPIC MONOPOLAR L HOOK IT BECAME STUCK ON THE END OF THE TROCAR SLEEVE, CAUSING DAMAGE. IT WAS LATER NOTED THAT THE L HOOK WAS BENT PRIOR TO GETTING STUCK ON THE TROCAR. NO DELAYS. PROCEDURE WAS COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861124 ↗
• MalfunctionAug 28, 2023Crack; Crack

  IT WAS DISCOVERED PRE UNKNOWN PROCEDURE, THAT THERE WAS A DENT IN THE TROCAR. NEW DEVICE USED. 5 MIN DELAY TO OPEN NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631069 ↗
• MalfunctionJun 15, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TWO DEVICES WERE BENT AND ONE HAD A WHOLE IN THE PACKAGING. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138203 ↗
• MalfunctionJun 1, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN DIAGNOSTIC LAPAROSCOPY WITH SALPINGECTOMY, THE 5MM TROCAR BROKE AT THE STEM WHILE INSIDE PATIENT (THIS WAS ABLE TO BE RETRIEVED). THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039702 ↗
• MalfunctionFeb 14, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A ESOPHAGECTOMY, TROCAR BROKE DURING USE. THE BROKEN PIECE HAS BEEN RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372178 ↗
• MalfunctionOct 26, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, DURING THE EXTRACTION THE DEVICE BROKE ON THE DISTAL SECTION RELEASING FRAGMENT INTO THE ABDOMEN (ALL DETECTED). NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674997 ↗
• MalfunctionAug 17, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A COLO RECTAL PROCEDURE THAT THE END OF THE TROCAR WAS BENT INSIDE THE PACKAGE AND UNABLE TO BE USED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245571 ↗
• MalfunctionJun 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THERE WAS A PACKAGING ISSUE. THERE WAS A HOLE IN THE PLASTIC. LIKE DEVICES WERE USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803198 ↗
• MalfunctionDec 21, 2021Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR DISINTEGRATED AND WENT INTO THE PATIENT AND HAD TO BE FISHED OUT. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052988 ↗
• MalfunctionAug 25, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, THE TIP BROKE OFF INSIDE THE PATIENT AS THE SURGEON WAS EXITING. THE TIP WAS FOUND AND REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368866 ↗