ENDOPATH XCEL OPTIVIEWRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 278
- Deaths reported
- 5
- Injuries reported
- 18
- Recalls
- 0
We found 12 models of ENDOPATH XCEL OPTIVIEW by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 278 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2017 and Aug 11, 2026 — classified as 5 deaths, 18 injuries, 255 malfunctions.
The most frequently reported specific device problem is “Crack” (114 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ENDOPATH XCEL OPTIVIEW problems
Device problems
- Crack114
- Material Integrity Problem52
- Delivered as Unsterile Product20
- Break18
- Material Separation16
- Manufacturing, Packaging or Shipping Problem14
- Gas/Air Leak12
- Insufficient Device Problem Information9
Patient problems
- No Clinical Signs, Symptoms or Conditions194
- No Consequences Or Impact To Patient57
- Foreign Body In Patient9
- No Code Available9
- Blood Loss7
- Tissue Damage6
- Unspecified Tissue Injury6
- Death5
ENDOPATH XCEL OPTIVIEW models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOPATH XCEL OPTIVIEW 2B12LTLaparoscope, general & plastic surgery1 death81 reports
- ENDOPATH XCEL OPTIVIEW 2H12LPLaparoscope, general & plastic surgery78 reports
- ENDOPATH XCEL OPTIVIEW 2B5LTLaparoscope, general & plastic surgery2 deaths54 reports
- ENDOPATH XCEL OPTIVIEW 2CB5LTLaparoscope, general & plastic surgery1 death18 reports
- ENDOPATH XCEL OPTIVIEW 2CB12LTLaparoscope, general & plastic surgery1 death15 reports
- ENDOPATH XCEL OPTIVIEW 2B5STLaparoscope, general & plastic surgery9 reports
- ENDOPATH XCEL OPTIVIEW 2B5XTLaparoscope, general & plastic surgery8 reports
- ENDOPATH XCEL OPTIVIEW 2D12LTLaparoscope, general & plastic surgery5 reports
- ENDOPATH XCEL OPTIVIEW 2D5LTLaparoscope, general & plastic surgery4 reports
- ENDOPATH XCEL OPTIVIEW 2B12XTLaparoscope, general & plastic surgery3 reports
- ENDOPATH XCEL OPTIVIEW 2CB5STLaparoscope, general & plastic surgery2 reports
- ENDOPATH XCEL OPTIVIEW 2D5STLaparoscope, general & plastic surgery1 report
Recent ENDOPATH XCEL OPTIVIEW adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Material Integrity Problem
It was reported that during an Unknown procedure, the 2B12LT trocar required cleaning to restore clear visualization. A wet sponge was twisted inside the trocar to remove debris; during this process, the valve became detached and fell into the patient. The trocar was subsequently replaced, and the detached valve was retrieved quickly and without difficulty. The event did not result in any procedural delay, and no patient impact was reported. This issue was never reported in the past.Has there been any harm reported to the patient or user? No.Has there been a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206934 ↗MalfunctionAug 5, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142528 ↗MalfunctionAug 5, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142513 ↗MalfunctionJul 7, 2026Crack
IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE MAIN BODY OF 2H12LP WAS BROKEN. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 25742138 ↗MalfunctionJul 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, MOISTURE INSIDE STERILE PACKAGING - NOTICED ON TABLE SET UP PRE-OP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716349 ↗MalfunctionJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING CLOSING OF WOUND, SURGEON NOTICED A TINY PIECE OF RUBBER ON PATIENT'S SKIN. IT LOOKED SIMILAR TO THE INTERNAL FLAPS OF THE DISPOSABLE SHEATH OF EXCEL BLADELESS TROCAR, SIMILAR TO EARLIER CASE WHEREIN THE SAME EVENT HAPPENED. CLINICAL STAFF CONFIRMED UPON CHECKING THE WASHER PART OF THE SAID SHEATH, THAT INDEED, A PIECE OF THE RUBBER FLAP PART IS TORN OFF." NO OTHER DETAILS PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 25585661 ↗MalfunctionMay 14, 2026Gas/Air Leak; Material Integrity Problem
IT WAS REPORTED THAT DURING THE UNK SURGERY, THE SURGEON NOTED THE DEVICE WITH AIR LEAKAGE ISSUE. 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 25176340 ↗MalfunctionMay 7, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING A ROBOTIC PARTIAL NEPHRECTOMY, TROCAR WAS BEING USED AND TWO WASHERS WERE FOUND TO HAVE DETACHED FROM THE DEVICE. ANOTHER TROCAR WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118225 ↗MalfunctionApr 9, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSIDE OF THE PACKAGING APPEARED CLOUDY, AS IF THERE WAS MOISTURE. ALTHOUGH IT SEEMED STERILE, THERE WERE CONCERNS, AND A REPLACEMENT WAS REQUIRED. THE ISSUE WAS FOUND DURING PICKING. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 24830387 ↗MalfunctionApr 9, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSIDE OF THE PACKAGING APPEARED CLOUDY, AS IF THERE WAS MOISTURE. ALTHOUGH IT SEEMED STERILE, THERE WERE CONCERNS, AND A REPLACEMENT WAS REQUIRED. THE ISSUE WAS FOUND DURING PICKING. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 24830376 ↗MalfunctionApr 9, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSIDE OF THE PACKAGING APPEARED CLOUDY, AS IF THERE WAS MOISTURE. ALTHOUGH IT SEEMED STERILE, THERE WERE CONCERNS, AND A REPLACEMENT WAS REQUIRED. THE ISSUE WAS FOUND DURING PICKING. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 24830350 ↗MalfunctionApr 9, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSIDE OF THE PACKAGING APPEARED CLOUDY, AS IF THERE WAS MOISTURE. ALTHOUGH IT SEEMED STERILE, THERE WERE CONCERNS, AND A REPLACEMENT WAS REQUIRED. THE ISSUE WAS FOUND DURING PICKING. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 24830313 ↗MalfunctionApr 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE NURSE FOUND THAT THERE WAS THE HOLE ON THE PACKAGE OF THE PRODUCT. SO THEY DIDN'T USE THIS PRODUCT. NO PATIENT INVOLVEMNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794011 ↗MalfunctionMar 26, 2026Mechanical Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE BLADE DID NOT RETRACT AND RESULTED IN AN INJURY. IT WAS A PATIENT WHO RECEIVED A SOMEWHAT SUPERFICIAL WOUND ON THEIR ABDOMEN WHEN THE SURGEON REMOVED THE TROCAR. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 24706343 ↗MalfunctionJan 14, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RECTAL SURGERY, BEFORE USED ON THE PATIENT, NOTED THE SEAL OF THE PACKAGING HAD BEEN OPENED. 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 24066436 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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