ENDOPATH XCEL OPTIVIEW 2B5STRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036013716), received between Nov 15, 2019 and Jan 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE 2B5ST SLEEVE IS TILTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955954 ↗
• MalfunctionDec 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, BEFORE AN UNKNOW LAPAROSCOPICALLY SURGERY, BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS A SCRATCH ON THE PACKAGE. IT WAS REFRAINED FROM USING IT AS A PRECAUTION. 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 23794229 ↗
• MalfunctionMay 1, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPPER PART OF TROCAR WAS BENT BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945130 ↗
• MalfunctionAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A GYN PROCEDURE, A 5MM TROCAR MALFUNCTIONED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048080 ↗
• MalfunctionJun 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN OB-GYN PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE PATIENT AND THE INNER CYLINDER WAS REMOVED, A RUBBER IN THE OUTER CYLINDER WAS CRACKED AND A PART OF IT FELL OFF INTO THE PATIENT. THE FALLEN PIECE WAS RETRIEVED. 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 14678017 ↗
• MalfunctionMar 23, 2022Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS DEFORMED WHEN THE PACKAGE WAS OPENED. 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 13861936 ↗
• MalfunctionAug 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE 2B5ST HAD A BROKEN INNER TUBE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329242 ↗
• MalfunctionJul 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE BLUNT TIP OF THE DEVICE WAS BROKEN OFF WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10322995 ↗
• MalfunctionNov 15, 2019Material Deformation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BLADDER TOTAL EXTIRPATION, THE OUTER SLEEVE OF THE 2B5ST TROCAR WAS DEFORMED DURING USE. THERE WAS A POSSIBILITY THAT THE OUTER SLEEVE TOUCHED THE A PROBE PLUS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9331224 ↗