ENDOPATH ATG45Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036001062), received between Jun 29, 2018 and Nov 8, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: SINGLE-INCISION LAPAROSCOPIC SURGERY FOR RECTAL CANCER: EARLY RESULTS AND MEDIUM-TERM ONCOLOGICAL OUTCOME. AUTHOR/S: K. GASH, M. BICSAK AND A. DIXON. CITATION: COLORECTAL DISEASE 2015 THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 17, 1071¿1078; DOI:10.1111/CODI.13034. THIS PROSPECTIVE ELECTRONIC DATABASE STUDY AIMED TO REPORT THE MEDIUM-TERM ONCOLOGICAL OUTCOME FROM A PROSPECTIVE OBSERVATIONAL STUDY OF SINGLE-INCISION LAPAROSCOPIC SURGERY (SILS) FOR RECTAL CANCER UNDERGOING HIGH AND LOW ANTERIOR RESECTION. BETWEEN 2009 AND 2014, 61 PATIENTS WITH RECTAL CANCER UNDERWENT SILS BY HIGH ANTERIOR RESECTION (N=34), LOWER ANTERIOR WITH TOTAL MESORECTAL INCISION[TME] (N=24), AND LOW ANTERIOR RESECTION WITH TME AND HAND-SEWN ANASTOMOSIS (N=3). DURING COLONIC MOBILIZATION, DISSECTION COMMENCED INFERIOR AND MEDIAL TO AN ELEVATED INFERIOR MESENTERIC ARTERY USING A HARMONIC ACE SCALPEL (ETHICON) AND HIGH DIVISION OF VEIN AND ARTERY WAS COMPLETED USING THE INSTRUMENT. THE RECTUM WAS THEN DIVIDED DISTAL TO THE TUMOUR IN AN ANTEROPOSTERIOR DIRECTION USING ATG45 (ETHICON ENDOCUTTER) ONE OR TWO STAPLE FIRINGS. DURING ANASTOMOSIS, AN END-TO-EN

  Patient problems: Abscess; Hematoma; No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 9294928 ↗
• InjuryJan 2, 2019Patient-Device Incompatibility

  IT WAS REPORTED THROUGH JOURNAL ARTICLE TITLE: ANALYSIS OF ENDOLOOPS AND ENDOSTAPLES FOR CLOSING THE APPENDICEAL STUMP DURING LAPAROSCOPIC APPENDECTOMY AUTHORS: MISLAV RAKIC, MIRO JUKIC, ZENON POGORELIC, IVANA MRKLIC, ROBERT KLICEK, NIKICA DRUZIJANIC, ZDRAVKO PERKO AND LEONARDO PATRLJ CITATION: SURG TODAY (2014) 44:1716¿1722; DOI 10.1007/S00595-013-0818-8; PUBLISHED ONLINE: 12 DECEMBER 2013. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY OF EACH TECHNIQUE BY FOCUSING ON THE INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS VERSUS COST. BETWEEN JUNE 2011 AND JUNE 2013, A TOTAL OF 333 PATIENTS (188 MALES AND 155 FEMALES WITH AGE RANGE FROM 5 TO 80 YEARS OLD) WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY (LA) WERE INCLUDED. THE DATA WERE GROUPED ACCORDING TO THE STUMP CLOSURE TECHNIQUE; A STAPLER GROUP (ENDOPATH-ENDOCUTTER ATG45, ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) (104 PATIENTS; 31.2 %) AND AN ENDOLOOP GROUP (VICRYL-ENDOLOOP 0; ETHICON ENDO-SURGERY, (B)(6) USA) (229 PATIENTS; 68.8 %). THE MESOAPPENDIX WAS DISSECTED, DEPENDING ON THE SURGEONS¿ PREFERENCES, WITH EITHER A HARMONIC SCALPEL (ULTRACISIONTM, ETHICON ENDO-SURGERY, (B)(6) USA), A BIPOLAR TISSUE SEALING SYSTEM (LIGASURETM, V

  Patient problems: Abscess; Blood Loss; No Code Available; Obstruction/Occlusion

  MAUDE report 8208219 ↗
• InjuryOct 1, 2018Break

  IT WAS REPORTED THAT THE FIRING TRIGGER DAMAGED. THE PATIENT IS WITH RECTUM CANCER. DURING THE ENDOSCOPIC RESECTION OF RECTUM, DURING THE FIRING, THE FIRING TRIGGER WAS DAMAGED. CHANGED TO THE OPEN SURGERY, USED CS40G TO COMPLETE THE SURGERY, THE SURGERY DELAYED ABOUT ONE HOUR. THE PATIENT IS STABLE AND LEFT FROM THE HOSPITAL.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7922723 ↗
• MalfunctionJun 29, 2018Failure to Fire

  IT WAS REPORTED THAT THE DEVICE COULD NOT FIRE. DURING THE DIXON, COULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651275 ↗