EEA OrVilRecalls & reported problems across all models

We found 4 models of EEA OrVil by Covidien LP in the FDA's device registry (GUDID). Together they are named in 440 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2016 and Sep 21, 2026 — classified as 6 deaths, 128 injuries, 306 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (166 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EEA OrVil problems

EEA OrVil models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EEA OrVil EEAORVIL25A

  STAPLE, IMPLANTABLE
  5 deaths355 reports
• EEA OrVil EEAORVIL21A

  STAPLE, IMPLANTABLE
  52 reports
• EEA OrVil EEAORVIL25

  STAPLE, IMPLANTABLE
  1 death27 reports
• EEA OrVil EEAORVIL21

  STAPLE, IMPLANTABLE
  6 reports

Recent EEA OrVil adverse event reports

The 15 most recent reports across all models, 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 ↗

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