EEA OrVil EEAORVIL25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 10884521042872), received between Aug 10, 2017 and Sep 21, 2026 — classified as 5 deaths, 93 injuries, 257 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (151 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 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842957 ↗
• MalfunctionSep 21, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840890 ↗
• MalfunctionAug 13, 2026Failure to Fire

  According to the reporter, during a laparoscopic radical resection for cardia cancer, during esophageal anastomosis, the device did not fire. A new Device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233139 ↗
• InjuryJul 7, 2026Break; Misassembly by Users

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE. THE SURGICAL TEAM NOTED THE INCOMPATIBILITY OF THE STAPLER AND THE ANVIL. THE PROCEDURE WAS CONVERTED TO OPEN. THE SURGICAL TIME WAS EXTENDED FOR ABOUT AN HOUR DUE TO THE ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 25728843 ↗
• InjuryJun 10, 2026Difficult to Remove; Failure to Form Staple; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DISTAL ESOPHAGECTOMY, THE STAPLE LINE WAS INCOMPLETE. A THORACOTOMY WAS PERFORMED TO RETRIEVE THE ANVIL. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT AND ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 25453373 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, WHEN THE CIRCULAR STAPLER WAS BEING APPLIED TO THE INTESTINE, THE ORVIL BROKE AND DISENGAGED. THE DEVICE WAS REPORTED TO HAVE BEEN PROPERLY LOADED, AND NO PIECES FELL INTO THE PATIENT CAVITY. THE PRODUCT WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225743 ↗
• MalfunctionMar 25, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CARDIAC SURGERY, WHEN BEING APPLIED IN THE ESOPHAGUS, THE ANVIL BROKE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689114 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT PRIOR TO USE, THE RETRIEVAL STRING OF THE CIRCULAR STAPLER BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681840 ↗
• InjuryMar 19, 2026Mechanical Jam

  ACCORDING TO THE REPORTER, DURING ESOPHAGOGASTRIC ANASTOMOSIS, THE ORAL ANVIL WAS ATTACHED TO THE STAPLER; HOWEVER, THE ANVIL DID NOT CHANGE FROM THE TILTED POSITION TO THE NORMAL (UPRIGHT) POSITION AT THE TIME OF ANASTOMOSIS. DESPITE ATTACHING AND DETACHING IT SEVERAL TIMES, THE ANVIL POSITION DID NOT CHANGE DURING FIRING. THE ANVIL HEAD OF THE ORAL ANVIL DID NOT RETURN TO THE UPRIGHT POSITION. AS A RESULT, THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY, EXTENDING THE SURGICAL TIME BY MORE THAN 60 MINUTES. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 24645299 ↗
• MalfunctionFeb 24, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, WHILE ON ANASTOMOSIS OF STOMACH TO THE SMALL INTESTINE, THE TROCAR AND ANVIL FAILED TO ATTACH AND THE METAL TIP WAS OPEN AND NOT SECURE WHEN INSERTED INTO THE STOMACH. THE DEVICE WAS PULLED OUT AND A NEW ORVIL WAS INSERTED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429751 ↗
• MalfunctionFeb 3, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE AS INTENDED. THE PHYSICIAN WAS UNABLE TO FIRE THE FIRST TWO DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICES WITH A NEW BOX CONTAINING A COMBINATION OF STAPLER AND ORAL ANVIL PRODUCTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249718 ↗
• MalfunctionFeb 2, 2026Detachment of Device or Device Component; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE ESOPHAGECTOMY, THE CIRCULAR STAPLER AND FIRST ANVIL WOULD NOT CONNECT AND SEAT PROPERLY. A NEW ANVIL WAS OPENED AND IT WAS VERY DIFFICULT TO CONNECT AND SET THE ANVIL TO THE STAPLER. AFTER MUCH TIME, WHICH EXTENDED 45 MINUTES, AND WORKING, THE ORANGE BAND WAS COVERED, THE SAFETY WAS ABLE TO BE RELEASED AND THE SURGEON FIRED THE STAPLER. AS THE SURGEON OPENED, TURNING THE BLACK WING NUT COUNTER CLOCKWISE TWO FULL TURNS, THE SURGEON FELT A CLICK AND REMOVED THE STAPLER FROM THE PATIENT CAVITY. AT THIS TIME THE STAPLER SEPARATED FROM THE ANVIL AND THE ANVIL REMAINED IN THE PATIENTS TISSUE. THE SURGEON WAS ABLE TO PULL IT THROUGH THE ANASTOMOSIS AND REMOVE IT FROM THE PATIENT. IT APPEARED THAT ALL THE STAPLERS WERE FORMED, HOWEVER, ALL OF THE TISSUE WAS NOT CUT. THERE WAS STILL SOME TISSUE AROUND THE ANVIL AND IT APPEARS THE KNIFE BLADE DID NOT FULLY CUT THE TISSUE. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24238698 ↗
• MalfunctionFeb 2, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE ESOPHAGECTOMY, THE CIRCULAR STAPLER AND FIRST ANVIL WOULD NOT CONNECT AND SEAT PROPERLY. A NEW ANVIL WAS OPENED AND IT WAS VERY DIFFICULT TO CONNECT AND SET THE ANVIL TO THE STAPLER. AFTER MUCH TIME, WHICH EXTENDED 45 MINUTES, AND WORKING, THE ORANGE BAND WAS COVERED, THE SAFETY WAS ABLE TO BE RELEASED AND THE SURGEON FIRED THE STAPLER. AS THE SURGEON OPENED, TURNING THE BLACK WING NUT COUNTER CLOCKWISE TWO FULL TURNS, THE SURGEON FELT A CLICK AND REMOVED THE STAPLER FROM THE PATIENT CAVITY. AT THIS TIME THE STAPLER SEPARATED FROM THE ANVIL AND THE ANVIL REMAINED IN THE PATIENTS TISSUE. THE SURGEON WAS ABLE TO PULL IT THROUGH THE ANASTOMOSIS AND REMOVE IT FROM THE PATIENT. IT APPEARED THAT ALL THE STAPLERS WERE FORMED, HOWEVER, ALL OF THE TISSUE WAS NOT CUT. THERE WAS STILL SOME TISSUE AROUND THE ANVIL AND IT APPEARS THE KNIFE BLADE DID NOT FULLY CUT THE TISSUE. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24238558 ↗
• InjuryJan 29, 2026Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A TOTAL GASTRECTOMY, DURING THE ANASTOMOSIS OF THE ESOPHAGEAL STUMP AND THE ELEVATED JEJUNUM, THE CIRCULAR STAPLER HANDLE AND THE ORAL ANVIL COULD NOT BE ATTACHED WHICH RESULTED IN THE ANASTOMOSIS BEING UNABLE TO BE PERFORMED. THE PROCEDURE WAS CHANGED FROM LAPAROSCOPY TO LAPAROTOMY AND THORACOTOMY. THE SURGICAL TIME WAS EXTENDED FOR THREE HOURS. IT WAS REPORTED THAT THE PATIENT HAD ACUTE ABDOMINAL PAIN POST-OPERATIVELY.

  Patient problems: Abdominal Pain; Failure to Anastomose; Laceration(s)

  MAUDE report 24209820 ↗
• MalfunctionJan 21, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ORAL ANVIL WAS DIFFICULT TO ATTACH TO THE STAPLER DURING SET-UP. THE DEVICE WAS REPLACED, AND ANOTHER ORAL ANVIL WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130770 ↗
• MalfunctionDec 18, 2025Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT DURING A ESOPHAGECTOMY, THE SHEATH WAS CUT TO SHORTEN IT AND, WITH THE WHITE PLASTIC INTRODUCER ATTACHED, THE TUBE COULD NOT BE DEPLOYED SUCCESSFULLY THROUGH THE OTOMY DUE TO KINKING. THE PROCEDURE WAS EXTENDED BY 15 MINUTES AS ATTEMPTS WERE MADE TO UNKINK THE PLASTIC, AND ANOTHER DEVICE WAS USED AT FULL LENGTH TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846392 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, ON THE ESOPHAGOJEJUNOSTOMY, AFTER FIRING THE ANTERIOR WALL SIDE HAD TYPE B INCOMPLETE STAPLE FORMATION. IT WAS NOTED THAT THE STAPLE LINE WAS INCOMPLETE. MANUAL SUTURING WAS PERFORMED TO REINFORCE THE STAPLE LINE. THE SURGERY WAS EXTENDED BY 30 MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 23800156 ↗
• InjuryDec 9, 2025Failure to Form Staple; Insufficient Device Problem Information; Failure to Form Staple; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, IN DIGESTIVE TRACT RECONSTRUCTION, THE DEVICE PARTIALLY FIRED, WHICH REQUIRED THE INCISION TO BE EXTENDED BY MORE THAN ONE INCH. A THORACOTOMY WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 23757809 ↗
• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, THE SUTURE REEL BROKE WHILE INSERTING THE DEVICE. AS A RESOLUTION, THE SURGEON REPLACED THE DEVICE WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348554 ↗
• MalfunctionSep 13, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SET UP PRIOR TO FIRING, THE SURGEON WAS UNABLE TO ATTACH THE ANVIL TO THE TROCAR TIP OF THE CIRCULAR STAPLER. AFTER MORE THAN HALF AN HOUR OF UNSUCCESSFUL ATTEMPTS, THE SURGEON DECIDED TO USE A COMPLETELY NEW SET OF CIRCULAR STAPLER HANDLE AND ORAL ANVIL. BY THAT TIME, THE OPENING IN THE STOMACH HAD ALREADY BEEN SIGNIFICANTLY WIDENED DUE TO REPEATED MANIPULATION OF THE ANVIL. WITH THE NEW SET, THE CONNECTION WAS SUCCESSFUL IMMEDIATELY. THE SURGEON HAD TO PLACE ADDITIONAL SUTURES TO REDUCE THE SIZE OF THE ORAL ANVIL ACCESS POINT IN THE STOMACH.

  Patient problems: Tissue Breakdown

  MAUDE report 23045865 ↗
• MalfunctionJul 28, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS DIFFICULTY ATTACHING THE ORAL ANVIL TO THE OPEN STAPLER. THE PROCEDURE WAS EXTENDED BY 30-35 MINUTES AS A RESULT. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 22629126 ↗
• InjuryJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC GASTRECTOMY INVOLVING AN ANASTOMOSIS OF THE SMALL BOWEL TO THE ESOPHAGUS, THE DEVICE SEPARATED FROM ITS TUBING DURING PASSAGE THROUGH THE MOUTH AND ESOPHAGUS. THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN SURGERY TO GAIN BETTER VISUALIZATION AND ACCESS PRIOR TO ANASTOMOSIS. THE ANVIL SEPARATION OCCURRED DURING THE DEVICE PASSAGE, BUT NO PIECES FELL INTO THE PATIENT CAVITY, AND NO IMAGING OR X-RAY WAS CONDUCTED. THE RETRIEVAL SUTURE ON THE ANVIL WAS USED TO RETRIEVE THE ANVIL FROM THE PATIENT, AND THE TUBING WAS REMOVED FROM THE ABDOMEN. ANOTHER DEVICE WAS USED TO COMPLETE THE ANASTOMOSIS.

  Patient problems: Laceration(s)

  MAUDE report 22546968 ↗
• MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THE ORAL ANVIL CATCHER DETACHED WHEN PULLED WITH SOME FORCE. THE CUSTOMER OPENED A NEW DEVICE TO CONTINUE WITH THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546773 ↗
• MalfunctionJul 3, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE DEVICE WAS BEING APPLIED TO THE ANASTOMOSIS. HOWEVER THE ORAL ANVIL WOULD NOT CONNECT TO THE STAPLER. TO RESOLVE THE ISSUE A NEW STAPLER AND ORAL ANVIL WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22400944 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANVIL GOT SEPARATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176299 ↗