ENDOPATH ATW45Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036001093), received between Jun 6, 2018 and Apr 27, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP APPENDECTOMY, THERE WAS A CRACKING SOUND WHEN FIRING, THEN THE HANDLE BECAME JAMMED AND THE JAW COULDN'T OPEN. SURGERY WAS DELAYED 60 MINUTES AND SCISSORS WERE USED TO CUT THROUGH TISSUE AROUND THE JAW, THEN IT WAS REPAIRED. ALL TROUBLE SHOOTING STEPS WERE TAKEN, BUT THE JAWS NEVER EVENTUALLY OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000546 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: USE OF TEMPORARY ESOPHAGEAL STENT IN MANAGEMENT OF PERFORATIONS AFTER BENIGN ESOPHAGEAL SURGERY. AUTHOR: FUMIAKI YANO, MD, AMR EL SHERIF, MD, CHARLES J. FILIPI, MD, AND SUMEET K. MITTAL, MD CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH (2008);18:283¿285. THE AUTHORS REPORTED A SERIES OF 3 PATIENTS WITH NON ANASTOMOTIC POSTSURGICAL ESOPHAGEAL LEAK SUCCESSFULLY TREATED BY TEMPORARY ESOPHAGEAL STENT. (PATIENT 2) A (B)(6) YEAR OLD MALE PATIENT WAS REFERRED FOR RECURRENT EPISODES OF IRON DEFICIENCY ANEMIA WITH HEMOGLOBIN AS LOW AS 2 G/DL IN WHICH THE ONLY IDENTIFIABLE CAUSE FOR RECURRENT ANEMIA WAS A LARGE INCARCERATED HIATUS HERNIA. THE PATIENT UNDERWENT A TRANSTHORACIC COLLIS-NISSEN PROCEDURE IN WHICH A 3-CM COLLIS GASTROPLASTY WAS PERFORMED WITH A GASTROINTESTINAL ANASTOMOSIS STAPLER (ENDO GIA, ATW 45, ETHICON) WITH A 46-FR BOUGIE PLACED IN THE ESOPHAGUS. REPORTED COMPLICATIONS INCLUDED MID ESOPHAGEAL LEAK, PERSISTENT SEPSIS, AND AIR LEAK IN THE MEDIASTINUM WELL ABOVE THE COLLIS SEGMENT IN WHICH 2 MEDIASTINAL DRAINS WERE PLACED THROUGH THE HIATUS AND BROUGHT OUT THROUGH THE ANTERIOR ABDOMINAL WALL AND A FEEDING JEJUNOSTOMY AND GASTROSTOMY TUBE

  Patient problems: Obstruction/Occlusion; Perforation of Esophagus; Sepsis

  MAUDE report 8917608 ↗
• MalfunctionDec 20, 2018Firing Problem

  APPENDECTOMY: ATW45 WAS FIRED ACROSS A TISSUE AND IT GOT LOCKED. THE SURGEON OPENED EC60A AND COMPLETED THE TRANSACTION WITH IT. JJM REP WERE NOT AT THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187272 ↗
• MalfunctionJun 6, 2018Failure to Form Staple

  STAPLES MALFORMED. DURING THE ENDOSCOPIC HEPATECTOMY, AFTER FIRED WITH TWO TR45WS, SOME OF STAPLES MALFORMED WITH IRREGULAR SHAPE. SUTURE WAS USED TO SEW THE WOUND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7572733 ↗