ENDOPATH UV120Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705036013426), received between Jul 9, 2018 and Aug 12, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (12 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220387 ↗
• MalfunctionDec 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING AN UNKNOWN UROLOGICAL 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 23801910 ↗
• MalfunctionOct 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PACKAGE IS DAMAGED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467150 ↗
• MalfunctionOct 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY SURGERY; DEVICE BROKE FROM THE TOP AND THE RED BALL INSIDE FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876709 ↗
• MalfunctionMar 2, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CUSTOMER RECEIVED THE PRODUCT FROM THE CARRIER AND THE ITEM IN QUESTION HAD THE PACKAGING VIOLATED, THUS LOSING THE STERILITY OF THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656827 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: GYNECOLOGIC PROCEDURE WITH ULTRA VERESS NEEDLE AND 363 PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, SURGICAL INJURY. THIS IS FOR ETHICON ENDOPATH ULTRAVERESS NEEDLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13173446 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: ABDOMINAL PROCEDURE WITH ULTRA VERESS NEEDLE AND 274 PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, SURGICAL INJURY. THIS IS FOR ETHICON ENDOPATH* ULTRAVERESS NEEDLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13173419 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: GYNECOLOGIC PROCEDURE WITH ULTRA VERESS NEEDLE AND 413 PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, BLEEDING. THIS IS FOR ETHICON ENDOPATH ULTRAVERESS NEEDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13173391 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: ABDOMINAL PROCEDURE WITH ULTRA VERESS NEEDLE AND 1,200 PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, BLEEDING. THIS IS FOR ETHICON ENDOPATH* ULTRAVERESS NEEDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13173291 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662633 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662576 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662561 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662372 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662342 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662320 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662278 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662205 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662161 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662030 ↗
• MalfunctionOct 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS DISCOVERED TO BE DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661903 ↗
• MalfunctionJan 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, THE DOCTOR REPORTED THAT THE DISPOSABLE (DEVICE) WAS DAMAGED (BENT) INSIDE THE PACKAGING AND THE SAFETY MECHANISM WAS NOT WORKING. THE PRODUCT WAS REPLACED AND DID NOT CAUSE DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240869 ↗
• MalfunctionMay 31, 2019Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING WAS COMPROMISED (SEMI-OPEN) STERILIZATION. WE REPORT THAT THERE WAS NO ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658263 ↗
• MalfunctionMar 20, 2019Obstruction of Flow

  TRIED TO INSUFFLATE DURING LAPAROSCOPIC APPENDECTOMY, INSUFFLATION TUBING WAS CONNECTED TO VERESS NEEDLE WHICH WAS IN PATIENT AND MONITOR STARTED FLASHING HIGH NUMBERS AND SAID IT WAS OCCLUDED. TOOK OUT OF PATIENT AND LOOKED AT TUBING AND VERESS NEEDLE AND NOTICED TIP OF VERESS NEEDLE WAS OCCLUDED AND AIR WAS NOT ABLE TO PASS THROUGH THE HOLE AT THE END. OPENED NEW VERESS NEEDLE TO USE DURING SURGERY AND SAVED OLD ONE TO BE SENT BACK TO MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8435630 ↗
• MalfunctionJul 9, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE TIP WAS FAULTY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669352 ↗