ENDOLOOP EJ10GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031206465), received between Mar 20, 2018 and Oct 27, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE BOX OF COATED ENDOLOOP CONTAINS A PROLENE SUTURE INSTEAD OF LABELED VICRYL SUTURE. STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024753 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE WAS LEFT INSIDE THE PATIENTS LEG. THE DEVICE WAS REMOVED AT A DIFFERENT ACCOUNT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17408482 ↗
• MalfunctionMar 20, 2018Hole In Material; Delivered as Unsterile Product

  SURGEON REQUESTED THE ENDOLOOP DURING A LAP CHOLE. THE PACKAGING IS THE SAME FOIL MATERIAL AS ANOTHER ETHICON PRODUCT STAFFS HAVE FACED ISSUES WITH. THE RN OPENED PACKAGE TO THE TECH, BUT INSTRUCTED THE TECH NOT TO PLACE ITEM ONTO THE SURGICAL FIELD AS IT MAY HAVE PIN-PRICK TYPE HOLES IN THE FOIL. AS EXPECTED, 8+ SMALL HOLES WERE FOUND IN THE PRODUCT, INDICATING A BREACH IN STERILITY THE TECH REMOVED THE ITEM AND HIS GLOVE TO RN TO PLACE INTO GARBAGE. THE TECH DONNED A NEW PAIR OF STERILE GLOVES ASEPTICALLY AND REPEATED PROCESS WITH SECOND ENDOLOOP PACKAGING INTACT. THE PACKAGING WAS SAVED FOR CLINICAL ENGINEERING, AND IMAGES OF THE PIN PRICK HOLES WERE ACQUIRED USING A MICROSCOPE LIGHT TO ILLUMINATE WHERE THE HOLES WERE LOCATED IN THE FOIL. PER SITE REPORTER: A COMPLAINT FILE HAS BEEN OPENED AND THE PACKAGE WILL BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 7352168 ↗