ENDOPATH XCEL OPTIVIEW 2B12XTRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves · Class 2
All models of ENDOPATH XCEL OPTIVIEW (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036014270), received between Jan 2, 2018 and Nov 13, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Crack1
- Device Contamination with Chemical or Other Material1
- Gas/Air Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DEVICE WAS IN AND OUT OF THE TROCAR, THE DISTAL PART OF THE TROCAR WAS PARTIALLY CRACKED. REMOVED THE FRAGMENT FROM THE BODY, AND REPLACED A NEW TROCAR TO CONTINUE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20676785 ↗MalfunctionJun 26, 2023Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS NOT AIR TIGHT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17199221 ↗MalfunctionJan 2, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THREE WEEKS AFTER THE PATIENT HAD A LAPAROSCOPIC LYSIS OF ADHESIONS, THE PATIENT HAD A ROBOTIC LAPAROSCOPIC GASTRIC BYPASS AND THE DOCTOR DISCOVERED A TROCAR SEAL ON THE OMENTUM, INSIDE THE PATIENT. THE SEAL WAS REMOVED FROM THE PATIENT. THE SECOND PROCEDURE WAS COMPLETED WITH NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Code Available
MAUDE report 7156920 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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