ENDOPATH XCEL OPTIVIEW 2D5LTRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Xcel with OPTIVIEW Technology Dilating Tip 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036013754), received between May 7, 2018 and Mar 11, 2025 — classified as 1 injury, 3 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. 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
- Crack2
- Break1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available2
- Blood Loss1
- No Consequences Or Impact To Patient1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS BROKEN AFTER PLACEMENT. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21574557 ↗MalfunctionFeb 18, 2022Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS BROKEN FROM THE MIDDLE DURING INSERTION INTO THE ABDOMEN. NO PIECES REMAIN IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13564042 ↗InjuryDec 3, 2018Patient-Device Incompatibility
LAPAROSCOPIC PROCEDURE FOR ENDOMETRIOSIS: (B)(6) 2018: TROCAR WENT IN AND SOMETHING WASN'T QUITE RIGHT. THE DOCTOR HAS TROUBLE DISENGAGING THE TROCAR AND REPORTED IT DIDN'T UNLOCK. SUBSEQUENTLY, THE PATIENT SUFFERED A TEAR IN THE AORTA. THE PATIENT HAS SURVIVED AT THIS STAGE WITH LONG TERM EFFECTS UNKNOWN AT THIS POINT. LAP PROCEDURE WAS CONVERTED TO OPEN SO THE AORTA COULD BE REPAIRED. PATIENT RECEIVED 3 UNITS OF PACK CELLS AND 2 UNITS OF PLATELETS. PATIENT IS NOW OUT OF ICU AND ON A WARD.
Patient problems: Blood Loss; No Code Available; Tissue Damage
MAUDE report 8124054 ↗MalfunctionMay 7, 2018Break
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7491652 ↗
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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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