ENDOPATH XCEL OPTIVIEW 2B5XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036013723), received between Apr 27, 2021 and Apr 24, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, NOTED THE DEVICE WAS DAMAGED . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21901070 ↗
• MalfunctionApr 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, NOTED THE DEVICE WAS DAMAGED . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 21901036 ↗
• MalfunctionApr 24, 2024Crack; Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175328 ↗
• MalfunctionJan 26, 2024Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, FOUND THE SLEEVE WAS DAMAGED AFTER OPENED THE PACKING. 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 18587956 ↗
• MalfunctionJan 25, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRIC RESECTION SURGERY, CRACK WAS FOUND ON THE SLEEVE AFTER OPENING THE PACKING. 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 18581332 ↗
• MalfunctionJan 17, 2024Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, SLEEVE FELL OFF AFTER OPENING THE PACKING. CHANGED TO A NEW DEVICE 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 18527868 ↗
• MalfunctionApr 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LAP SLEEVE GASTRECTOMY, THEY LACERATED THE LIVER WITH OUR TROCAR. REP REPORTED THIS WAS A LITTLE LACERATION. NO PATIENT CONSEQUENCE WAS REPORTED TO THE REP. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734809 ↗
• MalfunctionApr 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON LACERATED THE LIVER WITH OUR TROCAR. REP REPORTED THIS WAS A LITTLE LACERATION. NO PATIENT CONSEQUENCE WAS REPORTED TO THE REP. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733296 ↗