EEA EEATAID25DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20884521045719), received between Dec 18, 2017 and Jun 16, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC GASTRIC BYPASS, THE INTRODUCER WAS USED BEFORE THE CIRCULAR STAPLER MATED TO THE ORAL ANVIL, WHEN GRABBING THE INTRODUCER TO REMOVE FROM THE PATIENT IT WAS NOTICED THAT THE THE INSTRUMENT ACTUALLY SPLIT INTO 2 PIECES. THE DOCTOR WAS ABLE TO REMOVE THE REMAINING PIECE OF THE INTRODUCER OUT OF THE PATIENT'S ABDOMEN WITH A PAIR OF GRASPERS AND THE SAME ORAL ANVIL AND STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012486 ↗
• MalfunctionDec 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, WHEN THE SURGEON APPLIED THE INTRODUCER ONTO THE STAPLER AND AS THE DEVICE WAS INTRODUCED INTO THE ABDOMINAL CAVITY OF THE PATIENT THE INTRODUCER BROKE IN HALF. ANOTHER INTRODUCER WAS TRIED TO USE BUT IT BROKE AS WELL. THE SURGEON THEN OPENED A NEW STAPLER AND INSERTED IT WITHOUT USING INTRODUCER AND THE CASE WAS COMPLETED WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519423 ↗
• MalfunctionAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, THE DEVICE SNAPPED AT THE STEM AFTER BEING TORQUED UPON ENTRY INTO PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923314 ↗
• MalfunctionApr 11, 2019Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTRIC BYPASS, THE PART OF THE DEVICE BETWEEN THE DILATION HEAD AND THE CENTER ROD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503716 ↗
• MalfunctionApr 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SETTING UP PRIOR TO A GASTRIC BYPASS, THE SCRUB DISCOVERED THAT THE SPIKE WAS LOOSE IN THE ANVIL. IT FELL/PULLED OUT EASILY. THE DEVICE COULD NOT BE LOADED. A NEW ONE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8499292 ↗
• InjuryNov 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON CREATING THE GASTROJEJUNOSTOMY DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, A COMPONENT OF THE DEVICE STAYED WITH THE PATIENT. IT WAS ONLY DETERMINED AFTER THE OPERATION AND THEY HAD TO BE OPENED AGAIN. ALL PIECES WERE RETRIEVED AND A COMPUTED TOMOGRAPHY (CT) ABDOMEN WAS NEEDED TO LOCATE THE COMPONENTS. THEY DID A RE-INTERVENTION TO COMPLETE THE CASE AND THERE WAS AN EXTENSION OF INPATIENT STAY FOR 2 DAYS.

  Patient problems: No Code Available

  MAUDE report 8033098 ↗
• MalfunctionSep 26, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS SURGERY, THE INTRODUCER BROKE INTO TWO PIECES WHEN USED TO INTRODUCE THE CIRCULAR STAPLER INTO THE ABDOMINAL CAVITY. THE TWO PIECES OF THE DEVICE WERE REMOVED FROM THE PATIENT'S BODY. THEY DID NOT NEED A SECOND DEVICE, BECAUSE THE PRODUCT WAS ABLE TO INTRODUCE INTO THE BODY BEFORE IT BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7911475 ↗
• MalfunctionJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING INTRODUCING THE STAPLER ON A LAPAROSCOPIC GASTRIC BYPASS, THE ANVIL TILTED AFTER FIRING AND MESO HAS BEEN DAMAGE. THEY CLOSE THE DEFECT TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7659052 ↗
• MalfunctionJun 28, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INTRODUCER WAS SPIKED ON TO THE STAPLER AND THE STAFF OF THE INTRODUCER BROKE. THE SURGEON DID NOT WANT TO USE THE STAPLER AS THE SPIKE WAS LITTLE BENT, OPENED A SECOND STAPLER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7646141 ↗
• MalfunctionMay 9, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY REVISION, AFTER SUCCESSFULLY ATTACHING THE INTRODUCER TO THE STAPLING DEVICE AND CONFIRMING THE INTRODUCER 'CLICKED', THE SURGEON ATTEMPTED TO INSERT THE STAPLING DEVICE WITH ATTACHED STAPLER INSERTOR THROUGH THE PATIENT'S INCISION. WHILE MANEUVERING THE DEVICE TO DILATE THROUGH THE PATIENT¿S TISSUE, THE INTRODUCER PORTION COMPLETELY BROKE OFF. THE INTRODUCER NEVER MADE IT INSIDE THE PATIENT, AND ALL COMPONENTS OF THE DEVICE APPEARED TO BE RECOVERED AND SAVED FOR RETURN/INSPECTION. ANOTHER INTRODUCER WAS OPENED, WITH THE SAME LOT NUMBER, AND ATTACHED TO THE SAME STAPLER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498484 ↗
• MalfunctionMay 8, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE INTRODUCER WAS USED WITH A STAPLER FOR ABDOMINAL INSERTION, THE STEM APPARENTLY BROKE OFF FROM THE DEVICE. THE PHYSICIAN NOTICED THE STEM OF THE DEVICE WAS LYING IN THE PATIENT'S ABDOMEN AND HE REMOVED IT. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7496815 ↗
• MalfunctionFeb 12, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A BARIATRIC LAPAROSCOPIC PROCEDURE, THE DEVICE BROKE UPON ENTRY INTO ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7263526 ↗
• MalfunctionDec 18, 2017Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE ANVIL TILTED WHILE SURGEON WAS ATTEMPTING TO PLACE IN GASTROTOMY. THE SCRUB NURSE HAD DIFFICULTY GETTING THE INTRODUCER TO ATTACH TO THE SHAFT. SHE STATED THAT THEY USED TO CLICK OR POP INTO PLACE, BUT AS OF LATE SHE FEELS IT IS NOT STICKING INTO PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127231 ↗