EEA OrVil EEAORVIL21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10884521042858), received between Feb 10, 2017 and Dec 15, 2025 — classified as 19 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Device Slipped; Failure to Form Staple; Device Slipped; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE BYPASS PROCEDURE, THE SURGEON ENCOUNTERED RESISTANCE WHEN TIGHTENING THE STAPLER AFTER COUPLING THE ANVIL, BUT STILL MANAGED TO TIGHTEN IT COMPLETELY, REACHING THE GREEN ZONE. HOWEVER, DURING THE STAPLING PROCESS, NO STAPLES CAME OUT OR FORMED. AFTER ATTEMPTING TO REMOVE THE STAPLER, THE SURGEON DISCOVERED THAT STAPLES HAD EJECTED AT THE LEVEL OF THE SMALL INTESTINE, APPROXIMATELY 2-3 CM FROM THE ANASTOMOSIS AREA, AND HAD EMBEDDED INTO THE INTESTINAL WALL WITHOUT FORMING PROPERLY. IT WAS NOTED THAT THE STAPLES SCATTERED THROUGHOUT THE INTESTINE, REQUIRING MANUAL RETRIEVAL. THE ANASTOMOSIS WAS PERFORMED MANUALLY DUE TO DEVICE ISSUES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23804975 ↗
• InjuryApr 22, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE CIRCULAR STAPLER, THERE WERE SEVERAL ISSUES. THE PROCEDURE EXPERIENCED EXTENDED SURGICAL TIME DUE TO STAPLE LINE ISSUES AND STAPLE LINE BLEEDING. ADDITIONALLY, THE DONUT WAS INCOMPLETE OR MISSING AFTER THE FIRING OF THE STAPLER. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO ADDRESS THE INCOMPLETE DONUT ISSUE. THE PRODUCT WAS SUBSEQUENTLY EXPLANTED.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 21883173 ↗
• MalfunctionFeb 18, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THERE WERE ISSUES WITH THE ORVIL (ORAL ANVIL) AND EEA STAPLER. THERE WERE SET-UP ISSUES PRIOR TO FIRING, AND THE ORAL ANVIL WAS DIFFICULT TO ATTACH TO THE  STAPLER. THE PROCEDURE WAS EXTENDED BY UP TO 30 MINUTES AS THE DEVICES DID NOT CLICK INSIDE THE CAVITY AND WERE TRIED OUTSIDE THE PATIENT. THE DEVICES WERE REPLACED WITH NEW ONES, WHICH FUNCTIONED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394140 ↗
• MalfunctionOct 8, 2024Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, IT WAS DIFFICULT TO DISCONNECT THE ANVIL FROM THE PROBE. THE SURGEON HAD TO CUT BOTH WIRES TO REMOVE THE PROBE. THE WIRE COULD NO LONGER SLIDE. NO INTERVENTION WAS DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400329 ↗
• MalfunctionMay 19, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y GASTRECTOMY, UPON INITIAL ACCESS FOR THE TROCAR, THE TROCAR WAS LEAKING GAS DURING THE SURGERY WHEN A 5MM INSTRUMENT WAS INSERTED INTO IT, BUT IT DID NOT LEAK WHEN THE 12MM STAPLER WAS INSIDE THE PORT. THE SURGICAL TEAM HAD TO CUT BOTH SUTURES CONNECTED TO THE TUBING IN ORDER TO GET THE TUBING TO RELEASE FROM THE ANVIL. ALSO, A PIECE OF THE SUTURE THAT WAS ATTACHED TO THE SUTURE WHEEL WAS LEFT IN THE STAPLE LINE OF THE CIRCULAR ANASTOMOSIS. THE DEVICE WAS RETRIEVED BY A GI SCOPE WITH A GUIDE WIRE THAT HAS A GRASPER AT THE DISTAL TIP OF THE WIRE. THE SURGEON KEPT USING THE TROCAR THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348459 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WEDGE, WHILE USING THE CIRCULAR STAPLER, A COMPONENT DISENGAGED BUT IT DID NOT FALL INTO PATIENT CAVITY. WHEN USING THE LINEAR STAPLER, IT DID NOT FIRE AFTER PRESSING THE GREEN BUTTON AND SQUEEZING THE HANDLE. A NEW CIRCULAR STAPLER AND RELOAD WITH THE SAME LINEAR HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. PLI 30<(>&<)> 40: ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WEDGE, THE DEVICE WAS NOT CUTTING SUFFICIENTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104684 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN CREATING GASTROJEJUNAL ANASTOMOSIS, THE ORAL GASTRIC TUBE COULD NOT BE REMOVED FROM THE ANVIL BY ONLY CUTTING ONE SUTURE STRAND. TO RESOLVE THE ISSUE, BOTH STRANDS HAD TO BE CUT, AND SUTURES HAD TO BE REMOVED FROM THE ANVIL HEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944778 ↗
• MalfunctionAug 3, 2023Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE CREATING THE GASTROJEJUNOSTOMY, A CRACKING SOUND WAS HEARD WHEN THE DEVICE WAS FULLY SQUEEZED. UPON OPENING THE DEVICE, THE SURGEON OBSERVED THAT THE DEVICE PARTIALLY FIRED, THE STAPLES WERE ENTIRELY OPEN, AND THE DONUT WAS INCOMPLETE. IT WAS NOTED THAT THE DEVICE WAS APPLIED OVER A PREVIOUS STAPLE LINE. THE SURGEON HAD CUT THE TISSUE AROUND THE ANVIL PORTION IN ORDER TO REMOVE THE DEVICE. A NEW SET OF DEVICES WAS USED TO RE-STAPLE THE TISSUE. A LEAK TEST WAS THEN PERFORMED ON NEW GASTROJEJUNOSTOMY ANASTOMOSIS, AND IT PASSED. THIS LED TO ROUGHLY 25 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 17455000 ↗
• InjuryNov 8, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC ROUX-EN-Y JEJUNOSTOMY ANASTOMOSIS, THE STAPLE LINE WAS INCOMPLETE. THE ANASTOMOSIS HAD TO BE RESECTED AND REVISED WITH ANOTHER CIRCULAR STAPLER AS THERE WAS A HOLE IN THE ANASTOMOSIS FROM 9 TO 12 O'CLOCK RESULTING IN A SMALLER THAN INTENDED GASTRIC POUCH AND A SHORTER ROUX LIMB. THAT PATIENT HAD A DRAIN PLACED AS A RESULT OF THE MISHAP. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES TO CORRECT THE PROBLEM. THE PATIENT EXTENDED HOSPITALIZATION FOR TWO DAYS, INSTEAD OF ONE IF THERE WILL BE NO FURTHER COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15754825 ↗
• MalfunctionJun 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO REPORTER, DURING A LAPAROSCOPIC DUODENAL-JEJUNAL BYPASS WITH SLEEVE GASTRECTOMY PROCEDURE, WHILE PULLING THE ORVIL TUBING THROUGH THE STOMACH SLEEVE, THE SUTURE BROKE AT THE ATTACHMENT TO THE TUBING AS WELL AS THE SUTURES ATTACHED TO THE ANVIL. THE DETACHED ORVIL TUBING AND ANVIL WERE REMOVED, AND THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569236 ↗
• MalfunctionMay 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL RESECTION, AT THE ANASTOMOSIS OF THE ESOPHAGUS AND STOMACH, WHEN ATTEMPTING TO CONNECT THE CIRCULAR STAPLER ROD TO THE ANVIL, IT COULD NOT BE FULLY LOADED. AT THAT TIME, THE ORANGE BAND WAS NOT HIDDEN.  THE ANVIL USED WAS DISCONTINUED. TO RESOLVE THE ISSUE, THE SURGEON USED THE ANVIL INCLUDED WITH THE CIRCULAR STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307740 ↗
• InjuryMar 30, 2022Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER DURING THE GASTRIC ROUX EN Y CONVERSION VIA LAPAROSCOPIC WHILE PASSING DOWN THE ESOPHAGUS FOR THE GASTROJEJUNOSTOMY, THE USER COMPLAINED THE TUBING WAS NOT PASSING WITH EASE AND IT WAS TOO STIFF OF TUBING. DURING THE UPPER GI SCOPE THERE WAS SOME MINOR BLEEDING ATTRIBUTED TO TISSUE TRAUMA FORM PASSING THE TUBING. IT WAS NOTED THAT THERE WERE NO OTHER ACTIONS OR STEPS REQUIRED TO COMPLETE THE PROCEDURE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 13952596 ↗
• MalfunctionJan 21, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER DURING THE GASTRECTOMY WHILE IN ESOPHAGOJEJUNOSTOMY, THE SURGEON COMPLAINT ABOUT THE LABELING. SURGEON USED A STANDARD SIZED DEVICE DUE TO SMALL SIZED PATIENT AND DID NOT KNOW THAT THE STAPLER WAS FOR XL SIZE. THE ANVIL WOULD NOT MATE INTO THE HANDLE AND THE ANVIL LEGS BENT. THE SURGEON OPENED A NEW ONE AND IT ALSO DID NOT WORK. TO RESOLVE THE ISSUE, THE SURGEON SWITCHED STANDARD HANDLE TO XL SIZED AND THERE WAS AN EXTENDED SURGICAL EXTENSION OF 2 HOURS OR MORE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13323114 ↗
• MalfunctionOct 7, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS ON PATIENT WITH PREVIOUSLY RESECTED STOMACH, ORVIL PASSED TRANS ORALLY CORRECTLY. THE ORVIL ANVIL WAS BROUGHT THROUGH THE CREATED GASTRIC POUCH, WHEN ONE STRING WAS CUT OFF THE ORVIL, THE PLASTIC TUBING WOULD NOT COME OFF. THE SURGEON CUT THE OTHER STITCH TO REMOVE THE TUBING OF THE ORVIL AND MANUALLY PULLED OUT ANY REMAINING STITCHES FROM THE DEVICE. IT WAS NOTED THAT THE STAPLER WORK WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591063 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN CREATING THE GASTROJEJUNOSTOMY, THE RETRIEVAL SUTURE ON THE ORAL ANVIL DID NOT CUT WHEN THE STAPLER WAS FIRED. THERE WAS DIFFICULTY IN REMOVING THE STAPLER AND ORAL ANVIL FROM THE CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 12229169 ↗
• InjuryJun 29, 2021Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS WHILE BEING APPLIED FROM MOUTH TO STOMACH, THE ANVIL HAD A PIECE OF PLASTIC INSIDE STOPPING THE ANVIL FROM MATING WITH THE STAPLER. THE ORAL ANVIL HAD TO BE REMOVED FROM THE STOMACH AND ESOPHAGUS; HOWEVER, WHILE THE ANESTHESIOLOGIST PULLED THE STRINGS OF THE DEVICE, IT GOT STUCK ON THE GASTROESOPHAGEAL JUNCTION. THE ISSUE WAS RESOLVED WHEN A GASTROINTESTINAL DOCTOR AND ANOTHER SURGEON WERE CALLED INTO THE ROOM TO SCOPE THE PATIENT AND THE DEVICE WAS RELEASED AND REMOVED. A NEW ORAL ANVIL WITH THE SAME STAPLER WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12083971 ↗
• MalfunctionApr 7, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC BYPASS, DURING ANASTOMOSIS, THE ANVIL DID NOT DISLODGE WITHOUT CUTTING STRINGS. THE STRINGS OF THE ORAL ANVIL DID NOT PULL THROUGH AS INTENDED AND HAD TO BE CUT ON BOTH THE TUBE SIDE AND AFTER FIRING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628001 ↗
• MalfunctionOct 24, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN THE DEVICE WAS FIRED THERE WERE INCOMPLETE STAPLE LINE. TO RESOLVE THE ISSUE THE SURGEON HAD TO OVER-SEW THE TISSUE IN ORDER TO COMPLETE THE CASE. IN ADDITION THE REMOVAL OF THE TUBING-SUTURE ON ORVIL WAS DIFFICULT AND REQUIRED MORE FORCE TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10731901 ↗
• MalfunctionSep 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC ROUX EN Y BYPASS, THE ORAL ANVIL CAME APART FROM THE NASOGASTRIC/OROGASTRIC TUBE BEFORE IT ENTERED THE STOMACH.

  Patient problems: No Information

  MAUDE report 10511288 ↗
• MalfunctionAug 21, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y PROCEDURE, THE SURGEON WAS UNABLE TO REMOVE THE TUBE OF THE ORAL ANVIL ONCE ONE OF THE STRING WAS CUT. THE SURGEON HAD TO CUT THE SECOND DURING IN ORDER FOR THE TUBE TO BE REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435477 ↗
• InjuryJul 13, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y, WHEN THE DEVICE WAS INSERTED IN THE GASTROSTOMY, THE ORAL ANVIL DID NOT SEPARATE FROM THE TUBE. THE SURGEON HAD TO SUTURE OVER THE HOLES TORN IN THE STOMACH FROM THE SUTURES THAT WERE NOT REMOVED FROM THE ORAL ANVIL TUBE. THERE WAS TISSUE DAMAGE AS A RESULT OF THE EVENT.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10263484 ↗
• MalfunctionJun 19, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE WAS FIRED NORMALLY, BUT STRING DID NOT COME OUT WHEN THE TUBE WAS PULLED. THE STRING WAS CAUGHT IN THE STAPLE LINE. A BIOPSY SNARE WAS USED TO TAKE A STRING OUT OF THE STAPLE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173495 ↗
• MalfunctionJun 11, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y, AT THE TIME THAT THE STRING WAS CUT AND THE TUBE WAS SUPPOSED TO BE DISLODGED. THE TUBE DID NOT DISLODGE SO THE SURGEON CUT THE SECOND STRING AND THE TUBE FINALLY DISLODGED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142319 ↗
• InjuryJun 1, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHILE PERFORMING CREATION OF THE GASTRO-JEJUNO ANASTAMOSIS DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE SUTURE WOULD NOT RELEASE FROM THE ORVIL DEVICE RESULTING IN A TEAR IN THE GASTRIC POUCH. THERE WAS A TISSUE DAMAGE AS A RESULT OF THIS PROBLEM AND SUTURING WAS NEEDED TO REPAIR THE TEAR IN THE TISSUE AND COMPLETE THE CASE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10105870 ↗
• MalfunctionJan 29, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AFTER CUTTING ONE STRING TO DISENGAGE THE ANVIL FROM THE TUBING, THE SECOND STRING HAD TO BE CUT TO BE RELEASED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644644 ↗