ENDOPATH XCEL OPTIVIEW 2H12LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10705036014256), received between Dec 11, 2017 and Jul 7, 2026 — classified as 8 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Crack” (28 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 78 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJan 6, 2026Crack

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE OUTER CYLINDER OF THE TROCAR IS CHIPPED. NO ADVERSE EFFECTS ON 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 23973649 ↗
• MalfunctionDec 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING AN UNKNOWN SURGERY, A BLACK FRAGMENT WAS COME OFF FROM THE INSERTION HOLE. SINCE THE FRAGMENT WAS ABLE TO BE RETRIEVED, THERE IS NO RISK OF IT REMAINING INSIDE THE BODY. 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 23843412 ↗
• MalfunctionDec 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPIC SURGERY, THE ISSUE HAS REPORTED, BUT THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. 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 23801700 ↗
• MalfunctionDec 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, WHEN TRIED TO PUNCTURE THE TROCAR, A PART WAS BROKEN. FRAGMENTS HAVE ALSO BEEN 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 23715493 ↗
• MalfunctionOct 22, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC SURGERY, THE DEVICE WAS ONCE REMOVED TO TAKE A ¿SPECIMEN, AND WHEN TRYING TO INSERT AGAIN, IT WAS CRACKED. THERE WAS NO EFFECT ON 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 23356406 ↗
• MalfunctionApr 24, 2025Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA SURGERY, WHEN THE INNER CYLINDER TRIED TO INSERT AND JOINT, IT WOULD NOT GO IN. WHEN CHECKED THE OUTER SLEEVE, A WHITE COMPONENT WAS POPPING OUT AND BLOCKING THE HOLE. 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 21901658 ↗
• MalfunctionMar 25, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, DEVICE WAS BROKEN WHEN THE INNER TUBE WAS 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 21691186 ↗
• MalfunctionMar 25, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, IT WAS BROKEN AND FELL OFF WHEN IT WAS LEANED. 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 21691153 ↗
• MalfunctionMar 25, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE ENDOCATH BAG WAS INSERTED THROUGH THE TROCAR, THE ABDOMEN DEFLATED DUE TO THE TROCAR WINGS BREAKING OFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688575 ↗
• MalfunctionNov 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE VALVE CAME OFF DURING USE. NO PIECES WERE LEFT INSIDE 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 20734514 ↗
• MalfunctionOct 22, 2024Crack; Crack

  IT WAS REPORTED THAT DURING UNKNOWN SURGERY, THREAD-HANGING PART OF THE DEVICE WAS BROKEN. 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 20508113 ↗
• InjuryOct 10, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A ROBOTIC HERNIA PROCEDURE, PATIENT HAD GOTTEN SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20417800 ↗
• MalfunctionAug 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE FORCEPS WAS PUT IN THE CAMERA PORT, THE RUBBER INSIDE CAME OFF. 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 19919009 ↗
• MalfunctionJul 25, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, THE DEVICE HAD DAMAGED AFTER OPENING THE PACKAGE. A PART OF THE INNER TUBE HAD COME OFF. 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 19827594 ↗
• MalfunctionJun 18, 2024Difficult to Open or Remove Packaging Material; Manufacturing, Packaging or Shipping Problem; Difficult to Open or Remove Packaging Material; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ADNEXECTOMY, THE INNER CYLINDER DID NOT PULL OUT WHEN THE PACKAGE WAS OPENED AND THE DOCTOR TRIED TO PUNCTURE IT. 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 19556959 ↗
• MalfunctionMay 23, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INNER CYLINDER COULD NOT BE 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 19382279 ↗
• MalfunctionMay 23, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE 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 19381833 ↗
• MalfunctionApr 23, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PORT WAS DISASSEMBLED DURING PUNCTURE. 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 19167215 ↗
• MalfunctionApr 17, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS BROKEN BEFORE USE. 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 19127315 ↗
• MalfunctionApr 17, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, INNER CYLINDER COULD NOT BE REMOVED AFTER THE TROCAR WAS INSERTED. 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 19125830 ↗