ENDOPATH XCEL OPTIVIEW 2D12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036014232), received between May 31, 2019 and Mar 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A RIGHT COLECTOMY, ROBOT PROCEDURE, WHEN REMOVING THE NEEDLE, IT CAUGHT ON THE TROCAR VALVE. PART OF THE VALVE WAS TORN OFF BUT COULD BE SALVAGED. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903081 ↗
• MalfunctionAug 17, 2022Crack; Mechanical Problem; Crack; Mechanical Problem

  IT WAS REPORTED THAT DURING TO AN UNKNOWN PROCEDURE, THE TROCAR WHEN USED FALL APART. THE SURGERY WAS DELAYED BY 15 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE FRAGMENTS OUTSIDE OF THE PATIENT BUT IT DID NOT REQUIRE ANY INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245543 ↗
• MalfunctionAug 17, 2022Crack; Mechanical Problem; Crack; Mechanical Problem

  IT WAS REPORTED THAT DURING TO AN UNKNOWN PROCEDURE, THE TROCAR WHEN USED FALL APART. THE SURGERY WAS DELAYED BY 15 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE FRAGMENTS OUTSIDE OF THE PATIENT BUT IT DID NOT REQUIRE ANY INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245479 ↗
• MalfunctionFeb 28, 2020Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE WAS STUCK OUT OF THE TROCAR AND CANNOT PUSH RED BUTTON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770683 ↗
• MalfunctionMay 31, 2019Material Protrusion/Extrusion

  IT WAS REPORTED THAT AFTER THE BLADE WAS PRESSED, THE YELLOW TAB DIDN¿T COME BACK TO ITS PLACE. SO, THE KNIFE WAS EXPOSED AFTER ITS FIRST PENETRATION. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN IF THE SURGERY WAS DELAYED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658439 ↗