EEA EEAXL33Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523006179), received between Oct 29, 2018 and Feb 12, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2020Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN PERFORMING ANASTOMOSIS OF THE RECTUM TO COLON DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, THE SURGICAL ASSISTANT WAS UNABLE TO REMOVE THE DEVICE FROM THE ANUS. THE DEVICE WAS CAUGHT ON TISSUE. THE DEVICE WAS PUSHED SLIGHTLY INTO THE RECTUM TO CHECK IF IT WOULD DISLODGE, BUT IT DID NOT. THE WING NUT ON THE BACK OF THE DEVICE WAS HALF TURNED TO SEE IF THAT WOULD HELP. WHEN THE DEVICE WAS ROTATED AND PUSHED AGAIN, THE ANVIL DISENGAGED FROM THE DEVICE AND FELL INTO THE RECTUM. THE SURGEON INSERTED A SNAP TO TRY GRABBING THE ANVIL TO RETRIEVE AND MANEUVER IT OUT OF THE ANUS. THE ANASTOMOSIS WAS LOW ENOUGH THAT THE SNAP WAS ABLE TO GRAB THE ANVIL. WHEN THE SURGEON LOOKED AT THE ANVIL, IT TILTED, BUT IT DID NOT TILT ALL THE WAY AS IT USUALLY DOES. THE SURGEON CONFIRMED THAT THE ASSISTANT SURGEON TURNED FOUR HALF TURNS IN THE COUNTERCLOCKWISE DIRECTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700424 ↗
• InjuryDec 12, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSIT RECOVERING PROCEDURE, THE ANVIL WAS BROKEN. IT WAS ALSO REPORTED THAT THE TOP OF THE "STAPPER" WAS STUCK IN THE BOWL AND THE YELLOW PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY THE SURGEON. THE SURGICAL PROCEDURE WAS EXTENDED FOR ONE HOUR. A COLONOSCOPY WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 9457876 ↗
• InjuryOct 6, 2019Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, THE STAPLER FULLY FIRED AND LEAK TEST WAS NEGATIVE DURING A SIGMOIDECTOMY. THE VISUAL OF THE ANASTOMOSES ALSO LOOKED GREAT INSIDE AND THERE WERE TWO FULL DONUTS HOWEVER, THE PATIENT¿S ANASTOMOSES CAME APART AND THE ABDOMEN WAS FILLED WITH FECES 7 DAYS POST OPERATIVELY. IT WAS STATED THAT THE RECTUM WAS CLOSED AND AN ILEOSTOMY WAS CREATED. THEY HAD TO CLEAN THE PATIENT LAPAROSCOPICALLY AND THE SECOND SURGERY WAS EXTENDED TO 5 HOURS. THE PATIENT HAD AN OPEN PROCEDURE AND A WOUND VACUUM WAS PLACED. THE PATIENT IS STILL AT THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 9160304 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE ON COLON DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE SIZE MAY HAVE BEEN TOO LARGE AND TORE THE TISSUE. WHEN IT WAS EXTRACTED FROM THE PATIENT, THE STAPLE LINE SEEMED INTACT. THEY TRIED TO OVER SEW BUT TISSUE WAS BAD. EVENTUALLY, THEY REMOVED THE ANASTOMOSIS AND REDID WITH THE SAME DEVICE WHICH WAS SMALLER IN DIAMETER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8016157 ↗