ENDOPATH XCEL OPTIVIEW 2B12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10705036014218), received between Jan 12, 2018 and Aug 11, 2026 — classified as 1 death, 4 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Crack” (35 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 25 most recent of 81 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionDec 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RUBBER PIECE OF BLACK RUBBER FOUND INSIDE PATIENT DURING PROCEDURE. SURGEON OBTAINED PIECE AND REMOVED FROM PATIENT'S BODY, EQUIPMENT SEARCHED AND 5 12 EXCEL TROCAR LEAFLET HAD A HOLE THAT FIT THE OBTAINED RUBBER PIECE FROM PATIENT'S BODY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907572 ↗
• MalfunctionSep 10, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE TROCAR WAS BROKEN SO COULDN'T BE USED ON PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015135 ↗
• MalfunctionAug 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRECTOMY SURGERY, NOTED THAT UNIVERSAL HAP FELL OFF. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727850 ↗
• MalfunctionAug 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC RESECTION SURGERY, BEFORE USED ON THE PATIENT, NOTED THE UNIVERSAL HAP FELL OFF. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727653 ↗
• MalfunctionAug 5, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED GASTRIC MALIGNANT TUMOR RESECTION FOR GASTRIC CANCER, WHEN THE FORCEPS WERE INSERTED, THERE WAS A HISSING SOUND LIKE AIR LEAK. WHEN THE TROCAR WAS REPLACED, THE SOUND WHEN THE FORCEPS WAS INSERTED WAS RESOLVED, BUT AN AIR LEAK DID NOT RESOLVE, AND WHEN CHECKED THE EZ ACCESS OF THE UMBILICUS THAT WAS BEING USED AT THE SAME TIME, IT WAS FOUND TO BE TORN, SO IT WAS REPLACED AND AIR LEAK RESOLVED. IT IS UNKNOWN WHETHER THERE WAS A PROBLEM WITH THE TROCAR AS A RESULT. THE DEVICE WAS USED ON THE ABDOMINAL WALL. 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 22715116 ↗
• MalfunctionJun 2, 2025Crack; Crack

  IT WAS REPORTED THAT BEFORE A LAP HYSTERECTOMY SURGERY, SLEEVE FELL OFF AFTER OPENED THE PACKING. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122552 ↗
• MalfunctionMay 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THE SCRUB NURSE FOUND THAT THE BLACK COVER SEAL CAP ON THE TROCAR FELL OFF AND COULD NOT BE FASTENED AGAIN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008632 ↗
• MalfunctionMay 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE THE UNKNOWN SURGERY, NOTED THE SEAL WAS 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 21943337 ↗
• MalfunctionApr 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903140 ↗
• MalfunctionMar 20, 2025Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE THE UNKNOWN SURGERY, OPENED THE PACKING, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21656424 ↗
• MalfunctionMar 11, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN BARIATRIE PROCEDURE, TROCAR FELL APART DURING SURGERY. OPENED NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575309 ↗
• MalfunctionMar 4, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, NOTED THE DEVICE WAS DAMAGED. 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 21518240 ↗
• MalfunctionJan 29, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264352 ↗
• MalfunctionJan 22, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211019 ↗
• MalfunctionSep 27, 2024Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING ROBOTIC PROCEDURE, 2B12LT WAS USED AS THE OPERATING PORT IN A ROBOTIC CASE, REMOVED THE OUTER CASING OF THE TROCAR TO PERFORM A PUNCTURE, ONE OF THE 4 SEALS, PROBABLY A 2-LAYER, 4-PIECE SEAL, WAS INITIALLY REMOVED. THOUGHT IT WAS A PIECE OF VINYL AND USED THE PRODUCT. THE SAME DEVICE WAS USED AS IS 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 20321226 ↗
• MalfunctionSep 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SEALING PART OF THE VALVE FELL OFF WHEN FORCEPS WAS INSERTED OR REMOVED. 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 20250764 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE OBTURATOR SHAFT WAS BROKEN. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810263 ↗
• MalfunctionJul 2, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660553 ↗
• MalfunctionApr 17, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS NOTED THE DEVICE WAS BROKEN. 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 19127794 ↗