ENDOPATH ATW35Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705036012327), received between Dec 5, 2017 and Nov 25, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: USEFULNESS OF VESSEL-SEALING DEVICES COMBINED WITH CRUSH CLAMPING METHOD FOR HEPATECTOMY: A RETROSPECTIVE COHORT STUDY AUTHORS: ATSUSHI NANASHIMA, TAKAFUMI ABO, JUNICHI ARAI, KATSUNORI TAKAGI, HIROFUMI MATSUMOTO, HIROAKI TAKESHITA, TOMOSHI TSUCHIYA, TAKESHI NAGAYASU CITATION: INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 891-897. DOI: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2013.07.012. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY OF THE VESSEL-SEALING DEVICES FOR CONTROLLING BLOOD LOSS, TRANSECTION TIME AND POSTOPERATIVE COMPLICATIONS IN HEPATECTOMY AS A COHORT STUDY. THIS RETROSPECTIVE STUDY INVOLVES 267 PATIENTS WITH LIVER DISEASE WHO UNDERWENT HEPATIC RESECTION BETWEEN 2005 AND SEPTEMBER 2012. ONE HUNDRED EIGHTEEN PATIENTS UNDERWENT THE CONVENTIONAL CRUSH CLAMPING METHOD BETWEEN 2004 AND 2008 (CONTROL GROUP) AND 149 PATIENTS USED VESSEL SEALING DEVICES BETWEEN 2008 AND 2012 (VS GROUP). OF THE 149 PATIENTS IN THE VS GROUP, 120 PATIENTS (80 MALE AND 40 FEMALE) USED LIGASURE DEVICES AND 29 PATIENTS (20 MALE AND 9 FEMALE) USED HARMONIC FOCUS (ETHICON)(N-24; 15 MALE AND 9 FEMALE) OR HARMONIC ACE(ETHICON) (N-5; 5 MALE; MEAN AGE 58±

  Patient problems: Blood Loss

  MAUDE report 9368802 ↗
• InjuryNov 5, 2018Difficult to Open or Close

  IT WAS REPORTED THAT THE INSTRUMENT, ATW35, WAS PLACED OVER THE VESSEL (AS PART OF NEPHRECTOMY PROCEDURE) AND FIRED. WHEN THE SURGEON TRIED TO OPEN THE INSTRUMENT IT DID NOT OPEN SMOOTHLY. WHEN THE DEVICE WAS REMOVED FROM THE VESSEL THERE WAS BLEEDING FROM SOME KIND OF RIFT."

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8037806 ↗
• MalfunctionSep 20, 2018Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE WAS LOCKED OUT AT THE FIRST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895013 ↗
• MalfunctionJan 2, 2018Device Inoperable

  IT WAS REPORTED AT FIRST STAPLING, CLAMP DID NOT FUNCTION. IT LOCKED ON PATIENT BUT WAS REMOVE WITHOUT DIFFICULTIES. USE OF ANOTHER DEVICE. NO PATIENT CONSEQUENCES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7156574 ↗
• MalfunctionDec 5, 2017Mechanical Problem; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY PROCEDURE, THE STAPLER LOCKED OUT PRIOR TO FIRST FIRING. OPENED STAPLER, REMOVED FROM RENAL VEIN, NO STAPLES OR CUT LINE. OPENED LIKE DEVICE WAS FIRED, WORKED AS INDICATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084987 ↗