EEA OrVil EEAORVIL21Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521042841), received between May 23, 2018 and Sep 13, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC REVISION PROCEDURE, WHILE GJ (GASTROJEJUNOSTOMY) ANASTOMOSIS WAS BEING PERFORMED, THE WHITE SPIKE OR WHITE ADAPTER FELL INTO THE PATIENT'S CAVITY AND WAS NOT RETRIEVED. THE SURGEON WAS UNABLE TO LOCATE THE COMPONENT. THE PATIENT EXPERIENCED PAIN, THUS A CT SCAN WAS PERFORMED. THIS CONFIRMED A FOREIGN OBJECT WAS PRESENT IN THE PATIENT'S BODY. TWO TO THREE WEEKS FOLLOWING THE INITIAL SURGERY, THE PATIENT WAS BROUGHT BACK FOR REOPERATION TO REMOVE THE COMPONENT. THE WHITE PLASTIC PIECE WAS THEN SUCCESSFULLY REMOVED. IT WAS ALSO NOTED THAT ABSCESS HAD FORMED. THIS LED TO EXTENDED HOSPITALIZATION AND TEMPORARY INJURY. THE PATIENT WAS FINE AND HAD RECOVERED.

  Patient problems: Abscess; Foreign Body In Patient; Pain; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 15411551 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED IVOR LEWIS ESOPHAGECTOMY, A PROXIMAL INCISION OF THE ESOPHAGUS WAS MADE TO INSERT THE ANVIL AND A PURSTRING WAS PLACED TO SECURE THE ANVIL. THE STAPLER WAS PLACED IN THE DISTAL TISSUE, THE CENTER ROD WAS EXPOSED, THE ANVIL WAS MATED WITH THE CENTER ROD, THE STAPLER WAS CLOSED, GREEN WAS OBSERVED, THE SAFETY WAS RELEASED AND STAPLER WAS FIRED HEARING A CRUNCH SOUND. THE STAPLER WAS THEN OPENED AND AS THE ANVIL WAS TILTING, THE ANASTOMOSIS FELL APART. THE SURGEON NOTED STRAIGHT LEGS OF THE STAPLES (THERE WERE NO B-SHAPED STAPLES) AND NOTICED THAT THE ANVIL WAS STILL IN THE PROXIMAL PORTION OF THE TISSUE AS THE KNIFE BLADE DID NOT FULLY CUT THE TISSUE. THE SURGEON THEN PERFORMED A THORACOTOMY TO DETACH THE STAPLER FROM THE ANVIL, REMOVE THE ANVIL FROM THE PROXIMAL TISSUE BUT OPENING THE REMAINING PROXIMAL CUT LINE AND THEN HAND SEWED THE PROXIMAL TO THE DISTAL TISSUES FORMING A COMPLETED ANASTOMOSIS. AN ADDITIONAL 2.5 HOURS OF SURGERY WAS NEEDED TO COMPLETE THE CORRECTION OF THE MISFIRED ANASTOMOSIS. IT WAS STATED THAT 200 CC OF ADDITIONAL BLOOD WAS CAPTURED DUE TO THE MISFIRE AND CORRECTIONS. EXTENDED HOSPITAL STAY MAY HAPPEN AS A

  Patient problems: No Code Available

  MAUDE report 10013120 ↗
• MalfunctionMar 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING ESOPHAGUS PROCEDURE, WHEN THE SURGEON COMBINING THE ANVIL AND THE STAPLER, THEY COULD NOT BE FIXED PROPERLY AND ABNORMITY WAS FELT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850343 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE STUDY OF MINIMALLY INVASIVE OESOPHAGECTOMY PROCEDURE, THERE WERE 150 PATIENTS INCLUDED ON THE STUDY. THERE WERE 24 CASES INTRA-OPERATIVELY THAT WERE CONVERTED TO OPEN PROCEDURES FOR UNKNOWN REASON.

  Patient problems: No Code Available

  MAUDE report 9339411 ↗
• MalfunctionJun 28, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BANDING PROCEDURE, WHILE ON GASTROJEJUNOSTOMY, IT WAS DIFFICULT TO REMOVE THE STAPLER FROM THE CAVITY. THE ANVIL DID NOT TILT AFTER FIRING AND IT WAS CAREFULLY WORKED OUT OF THE ANASTOMOSES. IT TOOK A FEW ADDITIONAL MINUTES TO REMOVE THE ANVIL AND THIS RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645376 ↗
• MalfunctionMay 23, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE INTRODUCTION OF THE CATHETER INTO THE STOMACH IN A LAPAROSCOPIC ROUXEN GASTRIC BYPASS, THE TUBE DISLODGED FROM THE DEVICE PREMATURELY AND IT FELL INTO THE PATIENT¿S CAVITY. THEY WERE ABLE TO RETRIEVE THE DISTAL CAP OF THE DEVICE FROM THE PATIENT¿S CAVITY BY REMOVING THE DEVICE ORALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7537559 ↗