Endo GIA EGIAADAPTXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521201989), received between Aug 6, 2017 and Feb 8, 2022 — classified as 5 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (17 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, AT THE START OF THE SURGERY, THE STATE OF THE STATUS INDICATOR LIGHTS, 5 WHITE LIGHTS, HANDLE INDICATOR, ADAPTER INDICATOR, AND RELOAD INDICATOR WERE FLASHING. THE STAPLER WAS UNABLE TO FIRE, AND THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479940 ↗
• MalfunctionOct 5, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC PARTIAL COLLECTION, THE FIRING WAS NOT FINISHED. SURGEON REPLACED THE DEVICE WITH A MANUAL STAPLER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576961 ↗
• MalfunctionSep 8, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE HANDLE RECOGNIZED THE ADAPTER AND RELOAD, BUT THE TWO RELOADS WERE LOCKED AND NO LINES OF STAPLES CAME OUT AND DID NOT CUT. THERE WAS NO ISSUE NOTED ON THE BATTERY. A MANUAL HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440645 ↗
• MalfunctionNov 16, 2020Failure to Fire; Calibration Problem; Failure to Fire; Calibration Problem

  ACCORDING TO THE REPORTER, WHILE STAPLING DURING LAPAROSCOPIC GASTROPLASTY, THE ARTICULATION, ROTATION, CLOSING AND OPENING WERE SLOW AND DID NOT TRIGGER THE RELOAD. THE RELOAD WAS CHANGED, AND THE PROBLEM CONTINUED. THE ADAPTER WAS CHANGED, AND THE SAME RELOAD WORKED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844312 ↗
• MalfunctionJan 6, 2020Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IT WAS APPLIED ON THE ANTRUM SIDE, THE RELOAD WAS NOT GETTING UNLOADED FROM THE ADAPTER, THE STAPLER WAS NOT ABLE TO FIRE. THE JAWS OF THE DEVICE LOCKED ON THE TISSUE AND WAS REMOVED BY PULLING BACK WITH THE HELP OF A GRASPER. THE POWERED STAPLER WAS REPLACED WITH A MANUAL STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554918 ↗
• MalfunctionDec 3, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE FIRED, HOWEVER STOPPED HALFWAY RESULTING TO AN INCOMPLETE STAPLE LINE DISTALLY. 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 9403990 ↗
• MalfunctionMay 1, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTROPLASTY PROCEDURE, ON THE FIRST FIRING THE LOAD STOPPED IN HALF, NOT COMPLETING THE LINE OF CLAMPS. IT HAD TO BE REPLACED BY ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569292 ↗
• InjuryFeb 26, 2019Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOWER ANTERIOR RESECTION ON THE RECTUM, THE DEVICE, WAS UNABLE TO UNLOAD, BUT WAS ABLE TO FIRE THE JAWS OF THE DEVICE ALSO LOCKED ON TISSUE, THE DEVICE WAS UNABLE TO RETRACT POST FIRING. THERE WAS AN UNANTICIPATED TISSUE LOSS AS A RESULT OF THE PROBLEM. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH OR 2.54 CM. BECAUSE OF THE MISFIRING OF STAPLER, THE DOCTOR HAD TO DO A COLOSTOMY. THE RECTUM WAS RESECTED USING A MANUAL STAPLER AND THE INSTRUMENT WAS REMOVED TO COMPLETE THE CASE. THE PATIENT WAS STILL IN THE HOSPITAL. DUE TO THE ISSUE THE DOCTOR HAD TO PERFORM A COLOSTOMY.

  Patient problems: No Code Available

  MAUDE report 8371928 ↗
• MalfunctionFeb 12, 2019Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE RELOAD WAS DIFFICULT TO ATTACH INTO THE ADAPTOR AND THE DEVICE DID NOT FIRE. THEY USED ANOTHER RELOAD HOWEVER SAME PROBLEM OCCURRED, BUT WHEN THEY USED ANOTHER ADAPTER AND IT WORKED PERFECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331269 ↗
• MalfunctionFeb 6, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A GASTROPLASTY PROCEDURE, DURING THE STAPLING, THE STAPLES WERE NOT CORRECTLY FORMED. STAPLES ONLY SHAPED UP TO HALF. THERE WAS ALSO AN INCOMPLETE STAPLE LINE ON THE PROXIMAL PART. THEY REPLACED THE RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8311220 ↗
• MalfunctionJan 29, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, WHILE FIRING DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE STAPLER ONLY FIRED ABOUT HALFWAY AND STOPPED. IT WAS ALSO REPORTED THAT THE STAPLER WAS UNABLE TO BE OPENED. EVENTUALLY, THE SURGEON WAS ABLE TO PULL OUT THE STAPLER AND COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285010 ↗
• MalfunctionJan 24, 2019Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, WHEN CALIBRATING THE COMPONENTS THERE WAS NO SIGN OF ABNORMALITY. WHEN ATTEMPTING TO TRIGGER THE RELOAD BROKE OFF AND DID NOT FIRE, THE LOAD WAS DISCONNECTED, CONNECTED AND CALIBRATED AGAIN BUT THERE WAS NO LOADING DAMAGE. THE CALIBRATION PROCESS WAS PERFORMED AGAIN WITHOUT SUCCESS. THE RELOAD WAS REPLACED AND THE SURGERY WENT ON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8275497 ↗
• MalfunctionDec 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LARGE BOWEL RESECTION, THE SURGEON FIRED THE DEVICE AFTER ATTACHING THE RELOAD TO THE STAPLER, BUT THE DEVICE DID NOT FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175513 ↗
• MalfunctionNov 26, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, WHILE FIRING ON THE SMALL BOWEL CLOSING THE JEJUNOSTOMY ON A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE FIRED PARTIAL "B" STAPLES AND THEN THERE WERE NO MORE STAPLES DEPLOYED, THE STAPLE LINE WAS INCOMPLETE CENTRALLY. ANOTHER DEVICE WAS USED TO FIX THE STAPLE LINE AND COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101469 ↗
• MalfunctionNov 19, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHEN LOADING THE RELOAD, THE TECH WAS ABLE TO ARTICULATE THE RELOAD BUT THE JAWS OF THE DEVICE WOULD NOT CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083973 ↗
• InjuryOct 16, 2018Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOWER ANTERIOR RESECTION ON THE RECTUM, THE DEVICE, WAS UNABLE TO UNLOAD BUT WAS ABLE TO FIRE THE JAWS OF THE DEVICE ALSO LOCKED ON TISSUE, THE DEVICE WAS UNABLE TO RETRACT POST FIRING. THERE WAS AN UNANTICIPATED TISSUE LOSS AS A RESULT OF THE PROBLEM. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH OR 2.54CM. BECAUSE OF THE MISFIRING OF STAPLER, THE DOCTOR HAD TO DO A COLOSTOMY. THE RECTUM WAS RESECTED USING A MANUAL STAPLER AND THE INSTRUMENT WAS REMOVED TO COMPLETE THE CASE. THE PATIENT WAS STILL IN THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 7969196 ↗
• MalfunctionOct 5, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE POWERED STAPLER WAS UNABLE TO FIRE THE RELOAD LEADING TO AN INCOMPLETE DISTAL STAPLE LINE. IT WAS A PRESENTATION SO IT WAS UNNECESSARY TO FIX THE STAPLE LINE. THE JAWS WERE ARTICULATED AND THEY DID THREE ATTEMPTS WITH THREE DIFFERENT RELOADS BUT WERE UNSUCCESSFUL. AFTER APPLYING 1CM IT STOPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7938931 ↗
• InjurySep 19, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC RADICAL NEPHRECTOMY, ON THE HILUM OF KIDNEY, THE DEVICE WAS A POWERED STAPLER AND STOPPED FIRING ABOUT 20MM DOWN THE 60MM RELOAD. THE SURGEON DETERMINED THAT THEY NEEDED TO OPEN SINCE THEY COULD NOT 100% CONFIRM THAT ALL STAPLES WOULD BE COMPLETELY B-SHAPED OVER THE TISSUE. THE SURGEON DID NOT WANT TO TAKE IN EXCESSIVE BLEEDING OCCURRING LAPAROSCOPICALLY. THE SURGEON OPENED AND RETRACTED KNIFE BLADE OF THE DEVICE AND VESSELS WERE STILL INTACT AND NO BLEEDING ON THE HILUM. THE SURGEON CONTINUED WITH PROCEDURE AND USED MANUAL STAPLERS WITH RELOAD TO TAKE THE VESSELS AND REMOVE THE KIDNEY. THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE STAPLER WAS PARTIALLY FIRED. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE BECAUSE THE SURGEON HAD TO CONVERT TO OPEN PROCEDURE AND THE INCISION WAS EXTENDED BY MORE THAN 1 INCH.

  Patient problems: No Code Available

  MAUDE report 7891237 ↗
• MalfunctionSep 4, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE RESECTING THE STOMACH AND WHILE USING THE FIRST RELOAD, DURING A LAPAROSCOPIC MINI GASTRIC BYPASS, THE SURGEON PLACED THE JAWS ON THE STOMACH AND PRESSED THE GREEN BUTTON BUT THE STAPLER WAS NOT ABLE TO FIRE. THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. THEY REPLACED THE TAN RELOAD TO PURPLE AND THEN SWITCHED TO A DIFFERENT DEVICE SET TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7842331 ↗
• MalfunctionAug 22, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, STAPLE LOAD FAILED TO DEPLOY, IT WAS REMOVED AND REPOSITIONED AND STILL WOULD NOT WORK. THE DEVICE WAS REMOVED AND ANOTHER RELOAD WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7804849 ↗
• MalfunctionAug 14, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE 2ND FIRE ON THE STOMACH, THE STAPLES AND BLADE WOULD NOT DEPLOY. THIS DID NOT APPEAR TO BE A THICKNESS ISSUE AS WHEN THEY USED MANUAL HANDLE THE SURGEON WAS ABLE TO FIRE EASILY THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781547 ↗
• MalfunctionAug 14, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, FOR THE 2ND FIRING ON THE STOMACH, THE DEVICE DID NOT ADVANCE AND UNABLE TO FIRE. THE HANDLE WAS REPLACED WITH A MANUAL HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781523 ↗
• MalfunctionAug 7, 2018Difficult to Open or Close; Noise, Audible

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS SET UP DURING A ROUX-EN-Y PROCEDURE, A RELOAD WAS PLACED ONTO ADAPTER. THE JAWS WERE CLOSED BUT WERE UNABLE TO OPEN. THE DEVICE WAS FIRED AND A HIGH PITCH SQUEELING NOISE WAS HEARD FROM THE HANDLE. THE KNIFE BLADE WAS RETRACTED BUT JAWS WERE NOT ABLE TO OPEN. THE ADAPTER WAS TAKEN OFF WITH RELOAD ATTACHED, AND MANUAL TOOL WAS USED TO OPEN THE JAWS AND REMOVED THE RELOAD. THEY OPENED NEW DEVICE AND USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756903 ↗
• MalfunctionAug 2, 2018Misfire; Noise, Audible; Firing Problem; Misfire

  ACCORDING TO THE REPORTER, WHILE STAPLING SLEEVE DURING A LAPAROSCOPIC GASTRIC BYPASS SWITCH, THE STAPLER WAS VERY LOUD SOUNDING AND ONLY FIRED HALFWAY, ALSO THE STAPLE LINE WAS INCOMPLETE IN THE CENTRAL PART. THEY OPENED NEW STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742303 ↗
• MalfunctionJun 27, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING GASTRIC SLEEVE LAPAROSCOPY, THE STAPLER BEGAN TO FIRE AND STOPPED ON TISSUE ON THE STOMACH THAT SHOULD NOT HAVE BEEN TOO THICK. THEY OPENED A LAPAROSCOPIC HANDLE TO RESOLVE THE ISSUE AND CONTINUED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641393 ↗