EEA OrVil EEAORVIL25Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521042862), received between Mar 29, 2016 and Oct 23, 2023 — classified as 1 death, 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC BYPASS, AFTER FIRING THE CIRCULAR STAPLER, THE ANVIL DID NOT TILT. IT WAS ALSO MENTIONED THAT THE STAPLER WAS DIFFICULT TO REMOVE FROM THE CAVITY. AFTER SEVERAL MINUTES OF TRYING, THE DOCTOR WORKED FOR A TIME TO GET THE ANVIL TO FINALLY TILT AND WAS ABLE TO CAREFULLY REMOVE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986631 ↗
• MalfunctionJun 20, 2023Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY TOTAL GASTRECTOMY, WHEN CONNECTING THE STAPLER PART TO THE ANVIL, THE ANVIL SHOULD HAVE STRAIGHTEN, BUT THE ANVIL REMAINED TILTED EVEN WHEN IT WAS CONNECTED UNTIL THE ORANGE BAND WAS COVERED. DUE TO VARIOUS MOVEMENTS, THE ESOPHAGUS WAS RUPTURED. THE PURSE-STRING SUTURE WAS DONE AND ONCE AGAIN CHALLENGED. THE ANVIL WAS THEN TAKEN OUT AND CONNECTED OUTSIDE THE SURGICAL FIELD, AND THEN STRAIGHTENED UP. FIRING WAS DONE WITH THE SAME DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 15-20 MINUTES. THE SURGICAL INCISION WAS ALSO EXTENDED. AN UNANTICIPATED TISSUE LOSS AND DAMAGE WERE NOTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17163126 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC REVISION, WHEN PULLING ANTEGRADE DOWN THE ESOPHAGUS, THE ANVIL CAME OFF THE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538775 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC REVISION, WHEN PULLING ANTEGRADE DOWN THE ESOPHAGUS, THE ANVIL CAME OFF THE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537862 ↗
• MalfunctionAug 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE STAPLER AND ORVIL DID NOT ENGAGE. A NEW STAPLER AND ORVIL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234970 ↗
• MalfunctionJul 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN DEVICE WAS IN THE ESOPHAGUS DURING A LAPAROSCOPIC ESOPHAGECTOMY, THE ANESTHESIOLOGIST INSERTED THE ANVIL TUBE INTO THE PATIENT'S ESOPHAGUS TO BEGIN THE PROCESS OF STAPLING FOR THE ANASTOMOSIS. THE TUBE WAS INSERTED, BUT THE SURGEON COULD NOT PULL ANVIL THROUGH THE ENTEROTOMY. THE ANESTHESIOLOGIST PULLED ON THE BLUE SUTURES ATTACHED TO THE ANVIL TO RETRACT THE TUBE. THE SURGEON THEN MADE ANOTHER ATTEMPT TO PULL THE ANVIL THROUGH AND IT WOULD NOT PUNCTURE THROUGH ENTEROTOMY. THE SURGEON PULLED ON TUBE AGAIN AND IT DISCONNECTED FROM THE ANVIL. AT THAT TIME ALL PARTS OF THE ANVIL WERE REMOVED FROM THE PATIENT TRANS ORALLY AND A SECOND ANVIL DEVICE WAS SUCCESSFULLY USED TO CREATE THE ANASTOMOSIS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075078 ↗
• MalfunctionJan 15, 2021Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, THE ANVIL WOULD NOT TILT WHEN PAIRED WITH THE HANDLE. THE STAPLER WAS FIRED WITH EASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11177449 ↗
• InjuryMay 22, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. IT WAS ALSO REPORTED THAT THEY HAD DIFFICULTY USING THE ORVIL BUT THEY WERE ABLE TO CLOSE IT AFTER A WHILE. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES DUE TO USING A SUTURING DEVICE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 10084325 ↗
• InjuryApr 1, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED OCTOBER 2011 TO JANUARY 2015, IT WAS NOTED THAT AFTER USING THE DEVICE FOR AN ESOPHAGECTOMY PROCEDURE, IT WAS NOTED THERE WERE 2 PERIOPERATIVE DEATHS. FIRST DEATH DUE TO SEPSIS AND THE SECOND IS FROM COMPLICATIONS SECONDARY TO RADIATION PNEUMONITIS. THERE WERE LEAKS AND PATIENTS DEVELOPED SYMPTOMS OF DELAYED GASTRIC EMPTYING WERE SUCCESSFULLY TREATED WITH ENDOSCOPIC PYLORIC DILATION AND BOTULIN TOXIN INJECTION. THERE WAS ALSO EXTENDED HOSPITAL STAY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9910293 ↗
• InjuryDec 2, 2019Device Slipped; Misfire; Device Slipped; Misfire

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY PROCEDURE, THERE WAS AN INCOMPLETE DONUT FORMATION. IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY IN PAIRING THE ORVIL AND STAPLER TOGETHER. IT WAS ALSO CONFIRMED THAT THE ORANGE BAND WAS COVERED PRIOR TO FIRING. THE ANASTOMOSIS WAS SECURED WITH ADDITIONAL SUTURES. GASTROSCOPY WAS ALSO DONE TO MAKE SURE THERE WERE NO LEAKS. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 9398468 ↗
• MalfunctionOct 1, 2019Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A ESOPHAGECTOMY PROCEDURE, THE ANVIL/ORVIL AND THE STAPLER WOULD NOT CONNECT. THE ORVIL/ANVIL WAS REMOVED AND A NEW ORVIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143407 ↗
• InjuryMay 29, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A TOTAL GASTRECTOMY, IN THE ESOPHAGUS, WHEN MATING THE ANVIL TO THE TROCAR SPIKE THE ANVIL WOULD NOT STAY ENGAGED AND WOULD DISENGAGE MAKING IT UNABLE TO FIRE. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE AS A RESULT OF THIS PROBLEM, THE SURGEON HAD TO MAKE AN ADDITIONAL RESECTION ON THE ESOPHAGUS DUE TO DEVICE ISSUE. THE CASE WAS EXTENDED 30 MINUTES TO THE PRODUCT PROBLEM. ANOTHER STAPLER AND ANVIL WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8649630 ↗
• MalfunctionMay 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A ROBOTIC ASSISTED LAPAROSCOPIC TOTAL GASTRECTOMY. ORAL ANVIL WAS PLACED AT THE ESOPHAGEAL STUMP DURING R-Y RECONSTRUCTION AND THE HANDLE WAS INSERTED AT THE JEJUNUM SIDE. CENTER ROD WAS EXTENDED AND WAS CONNECTED TO THE ANVIL. IT WAS VISUALLY CONFIRMED THAT THE ANVIL WAS INSERTED UNTIL THE ORANGE BAND, BUT WHEN TRYING TO CONNECT THE HANDLE AND THE ANVIL, BUT THE ANVIL DISCONNECTED IN THE MIDDLE. AFTER THE SAME PROCESS WAS REPEATED, GRASPING FORCEPS WERE USED TO HELP PREVENT THE ANVIL FROM DISCONNECTING, AND THE HANDLE AND THE ANVIL WERE CONNECTED SOMEHOW. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8622590 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2011 UNTIL AUGUST 2012, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. NINE OF THE 45 PATIENTS WERE UNDER GROUP 1 WHEREIN A CIRCULAR STAPLER WITH AN ORAL ANVIL WAS USED TO CREATE THE INTRATHORACIC ANASTOMOSIS. FOUR OF THE NINE PATIENTS HAD AN ANASTOMOTIC LEAK AND UNDERWENT RE-OPERATION WHILE ONE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. SIX PATIENTS HAD DEVELOPED PULMONARY COMPLICATIONS; FIVE PATIENTS DEVELOPED CARDIAC COMPLICATIONS AND THREE PATIENTS WERE READMITTED TO THE ICU.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 8420101 ↗
• InjuryAug 23, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, ON CREATING GASTROJEJUNOSTOMY, THE SURGEON STATED THAT THE ANVIL PULLED OUT OF THE GASTROTOMY WHEN THEY ATTEMPTED TO MATE THE ANVIL AND TROCAR OR SPIKE. THE DEVICE DID NOT FIRE DUE TO THE INSTRUMENT ISSUE. THE SURGEON ALLEGES THAT THE ANVIL NEVER FLIPPED UP FROM ITS ORIGINAL TILTED POSITION AND THUS WAS PULLED THROUGH THE GASTRIC POUCH WITH ORDINARY EFFORT. THE SURGERY WAS EXTENDED BY ROUGHLY ONE HOUR PER THE SURGEON¿S STATEMENT. THEY ATTRIBUTED THIS TO USING THE DEVICE IN EVERY CASE AND BEING OUT OF PRACTICE WITH A ¿PO¿ EAR STAPLED ANASTOMOSIS FOR THE GASTROJEJUNOSTOMY. THE SURGEON COMPLETED THE CASE BY USING LINEAR ENDOSTAPLERS TO CREATE A SIDE-TO-SIDE ANASTOMOSIS.

  Patient problems: No Code Available

  MAUDE report 7809203 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS FINE AFTER THE INITIAL OPERATION OF ESOPHAGECTOMY BUT EVENTUALLY DEVELOPED BLEEDING. THE SURGEON SAID THAT THE DEVICES WORKED AS INTENDED DURING THE INITIAL PROCEDURE NEARLY A YEAR AGO. THE ANASTOMOSIS WAS CREATED, A LEAK TEST WAS PERFORMED AND THE CASE WAS COMPLETED, BUT THE ISSUE AROSE POST OPERATIVELY AS THE PATIENT DID NOT DO WELL AND HAD RECURRENT BLEEDING AT THE ANASTOMOTIC SITE. THE PATIENT WAS READMITTED TO CONTROL THE ACTIVE BLEEDING AND UNDERWENT AN ANGIOGRAM TWICE.

  Patient problems: No Code Available

  MAUDE report 7794368 ↗
• DeathJun 28, 2018Failure To Adhere Or Bond; Positioning Problem; Failure To Adhere Or Bond; Positioning Problem

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY PARTIAL GASTRECTOMY PROCEDURE, THE ORVIL WOULD NOT CONNECT TO THE STAPLER. THE DEVICE WAS DIFFICULT TO LOAD AND WAS UNABLE TO CLOSE. TO RESOLVE THE ISSUE, THEY OPENED A NEW STAPLER AND ATTACHED IT TO THE SAME ORVIL. THE PATIENT WAS VERY SICK AND DIED LATER IN THE HOSPITAL. THIS WAS NOT RELATED TO THE SURGERY.

  Patient problems: Death

  MAUDE report 7646039 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, AFTER CREATION OF THE GASTROJEJUNAL ANASTOMOSIS, THERE WAS A SURGICAL SITE INFECTION WHERE THE ANVIL WAS REMOVED FROM THE ABDOMEN. THE EVENTS LEAD TO OR EXTENDED THE PATIENT¿S HOSPITALIZATION FOR ONE OBSERVATION DAY. TREATMENT OF THE SURGICAL SITE INFECTION WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7602156 ↗
• InjuryJun 13, 2018Failure To Adhere Or Bond; Difficult to Remove; Failure To Adhere Or Bond; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY, WHILE BEING APPLIED AT THE ANASTOMOSIS, JEJUNUM AND ESOPHAGUS, THE ANVIL FROM A STAPLER DID NOT MATCH WITH THE DEVICE BECAUSE THE TROCAR WENT BACKWARDS AND THE KNOB TURNED IT SELF ALONE. THE SURGEON DECIDED TO PROCEED WITH AN OPEN PROCEDURE INSTEAD OF LAPAROSCOPIC ONE, AND AGAIN TRIED TO MATCH THE SAME ANVIL WITH THE SAME DEVICE, BUT SAME SITUATION HAPPENED WITH THE TROCAR AND KNOB. BECAUSE OF THE LONG ESOPHAGUS MANIPULATION WITH THIS MATCHING ACTION, THE TISSUE WAS AFFECTED AND A STENT HAD TO BE IMPLANTED AND THE ANASTOMOSIS WAS HAND SEWN. THE ANVIL COULD NOT BE TILTED AFTER FIRING AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. TO RESOLVE THE ISSUE, THE SURGEON REVIEWED THE STEPS TO USE THE PRODUCT AND ALSO TALKED TO THE CLINICAL AND PRODUCT SPECIALIST REGARDING THE STEPS TO FOLLOW. THE PATIENT HAD INCURRED A TEMPORARY INJURY.

  Patient problems: No Code Available

  MAUDE report 7597990 ↗
• MalfunctionApr 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY WHILE BEING APPLIED AT THE ANASTOMOSIS, THE SUTURE BROKE AND WAS DIFFICULT/UNABLE TO OPEN. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390378 ↗
• MalfunctionMar 1, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, THE ANVIL WAS SEPARATE FROM THE NG TUBE BEFORE TO USE. THERE WAS NO MEDICAL INTERVENTION AND NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7307827 ↗
• MalfunctionJan 7, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  ACCORDING TO THE REPORTER: WHEN PULLING THE DEVICE TOWARDS THE ESOPHAGUS, THE THREAD BETWEEN THE ANVIL AND THE GUIDING TUBE BROKE. THE ANVIL WAS STUCK AT THE PHARYNGEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170926 ↗
• InjuryOct 26, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, WHEN PREPARING TO ANASTOMOSE DURING LAPAROSCOPIC GASTRIC CANCER SURGERY, THE CONNECTION BETWEEN THE STAPLER AND THE ANVIL BROKE AND THE ANVIL HEAD FELL INTO THE STOMACH OF THE PATIENT. IT WAS CONVERTED TO OPEN SURGERY DUE TO DEVICE'S PROBLEM AND THE STAPLE'S ANVIL HEAD WAS REMOVED THROUGH THE USE OF A GASTROSCOPE TO LOCATE IT. THE OPERATION WAS EXTENDED FOR 30 MINUTES OR MORE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6980038 ↗
• MalfunctionSep 18, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, OCCURRED DURING A LAPAROSCOPIC TOTAL GASTRECTOMY. A COMPONENT OF THE DEVICE DISENGAGED INTO THE PATIENT CAVITY. IT WAS RETRIEVED. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872728 ↗
• InjuryAug 22, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER: AS PER THE ADDITIONAL INFORMATION RECEIVED, REDO ANASTOMOSIS USING ANOTHER DEVICE. THERE WERE NO PROBLEM DURING THE ORIGINAL SURGERY. PATIENT STATUS: DISCHARGED.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 6811351 ↗