EsophyX2 HD R2005Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00810275011065), received between Jan 14, 2016 and Aug 13, 2019 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2019Appropriate Device Problem Term/Code Not Available; Firing Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem

  THE PHYSICIAN REPORTED A MUCOSAL TEAR OCCURRED DURING A CONCOMITANT HIATAL HERNIA REPAIR AND TIF PROCEDURE. NO MEDICAL INTERVENTION WAS PERFORMED TO TREAT THE MUCOSAL TEAR AND NO LEAKS WERE NOTED DURING THE POST-PROCEDURE EGD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECONDARY ESOPHYX DEVICE. THE DAY AFTER THE PROCEDURE THE PATIENT RETURNED TO THE HOSPITAL AND EMERGENCY SURGERY WAS PERFORMED TO TREAT ESOPHAGEAL AND GASTRIC LEAKS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON AN UNKNOWN DATE. THE PHYSICIAN ALLEGES A STYLET PUNCTURED THE TISSUE MULTIPLE TIMES WITHOUT A FASTENER, THUS CONTRIBUTING TO THE NOTED LEAKS.

  Patient problems: No Code Available

  MAUDE report 8890520 ↗
• InjuryApr 23, 2018Device Issue; Device Issue

  THE PHYSICIAN NOTED THE SILICONE ENDOSCOPE RETAINER BAND WAS BROKEN IMMEDIATELY AFTER DEVICE INSERTION AND A PORTION OF THE RETAINER BAND HAD SEPARATED FROM THE DEVICE AND WAS LAYING IN THE PATIENT'S STOMACH. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE SEPARATED PORTION OF THE RETAINER BAND AND SUCCESSFULLY COMPLETED THE TIF PROCEDURE. DURING THE POST-PROCEDURE EGD, AN ESOPHAGEAL PERFORATION (THE SIZE WAS NOT REPORTED) WAS NOTED JUST PROXIMAL TO THE MOST PROXIMAL DEPLOYED FASTENER IN THE GEJ. THE PHYSICIAN SUCCESSFULLY TREATED THE PERFORATION USING A STENT AND SUTURES. THE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2018 AND WAS DISCHARGED (B)(6) 2018.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7452100 ↗
• MalfunctionJan 8, 2018Detachment Of Device Component

  THE USER REPORTED WHILE ATTEMPTING TO DISENGAGE THE HELICAL RETRACTOR FROM TISSUE, THE INNER SLIDE TUBE (WITH THE RETRACTOR KNOB) SEPARATED FROM THE RETRACTOR DRIVE CABLE AND PULLED OUT OF THE DEVICE. AS A RESULT, THE USER INTERVENED BY ACCESSING THE REMAINING RETRACTOR DRIVE CABLE AND USING HEMOSTAT CLAMPS TO DISENGAGE THE HELICAL RETRACTOR FROM TISSUE. THE INITIAL DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECONDARY R2005 DEVICE. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173931 ↗
• MalfunctionOct 20, 2017Bent

  THE USER REPORTED THE HELICAL RETRACTOR (BOTH THE HELIX AND CENTERING NEEDLE) WERE BENT/CURVED. AS A RESULT, THE USER WAS UNABLE TO ENGAGE TISSUE. THE INITIAL DEVICE WAS UNEVENTFULLY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECONDARY R2005 DEVICE. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6967179 ↗
• InjuryJun 22, 2017Use of Device Problem; Use of Device Problem

  PRIOR TO DEVICE INSERTION, THE USER REPORTED ISSUES WITH VIDEO OUTPUT FROM THE ENDOSCOPE. INSERTION OF THE DEVICE WAS INITIALLY ATTEMPTED WITHOUT ENDOSCOPIC VISUALIZATION OF THE ESOPHAGUS AND THE USER REPORTED DIFFICULTY INSERTING THE DEVICE. AN EGS REPRESENTATIVE PRESENT AT THE PROCEDURE, REPORTED THE USER USED AN ABNORMALLY LARGE AMOUNT OF FORCE DURING INSERTION. ON THE THIRD ATTEMPT, THE DEVICE WAS SUCCESSFULLY INSERTED INTO THE PATIENT BUT WAS QUICKLY REMOVED AS NO ENDOSCOPIC VISUALIZATION COULD BE ACHIEVED. AFTER FIXING THE ENDOSCOPE VIDEO ISSUE, THE USER REINSERTED THE ENDOSCOPE INTO THE PATIENT AND NOTED BLOOD PRESENT IN THE ESOPHAGUS. IN AN ATTEMPT TO LOCATE THE SOURCE OF THE BLEEDING, THE USER EXTERNALLY OPENED THE PATIENT'S ABDOMEN AND NECK. A PERFORATION WAS FOUND IN THE PROXIMAL ESOPHAGUS MID-CHEST APPROXIMATELY IN THE SAME LOCATION AS RESISTANCE WAS FELT DURING DEVICE INSERTION. THE PERFORATION WAS SUCCESSFULLY TREATED AND THE PATIENT WAS ADMITTED TO THE ICU (B)(6) 2017. AS OF (B)(6) 2017, THE PATIENT WAS STILL IN THE ICU IN STABLE CONDITION AND CONTINUES TO IMPROVE. THE USER VERBALLY STATED THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

  Patient problems: Perforation of Esophagus

  MAUDE report 6662379 ↗
• MalfunctionMay 23, 2017Device Operates Differently Than Expected; Difficult to Open or Close

  THE USER REPORTED THE TISSUE MOLD WOULD NOT OPEN OR CLOSE AS EXPECTED. AS A RESULT, THE USER WAS UNABLE TO MANIPULATE THE TISSUE MOLD TO PROPERLY POSITION TISSUE. THE INITIAL DEVICE WAS UNEVENTFULLY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECONDARY R2005 DEVICE. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6586499 ↗
• MalfunctionMay 13, 2017Loose or Intermittent Connection; Device Operates Differently Than Expected; Material Protrusion/Extrusion

  AFTER DEPLOYING TWO SETS OF FASTENERS IN ONE LOCATION AND MOVING TO A SECOND LOCATION, THE USER REPORTED THE HELICAL RETRACTOR "FELT LOOSE" AND "DIDN'T FEEL RIGHT" AND MADE AN UNSUCCESSFUL ATTEMPT TO ENGAGE TISSUE. UPON VISUAL INSPECTION BY THE USER, IT WAS OBSERVED THE HELIX WAS PROTRUDING 90-DEGREES FROM THE DISTAL END OF THE TISSUE MOLD. AN ATTEMPT TO STRAIGHTEN THE HELIX USING THE ENDOSCOPE WAS UNSUCCESSFUL. THE USER SUBSEQUENTLY ATTEMPTED TO STRAIGHTEN THE HELIX USING THE ENDOSCOPE GRASPER BUT WAS UNSUCCESSFUL. AFTER THE UNSUCCESSFUL ATTEMPTS, THE ENDOSCOPE GRASPER WAS USED TO COVER THE HELIX TO SAFELY REMOVE THE DEVICE. A SECONDARY R2005 DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6566068 ↗
• MalfunctionApr 12, 2017Break

  THE SURGEON REPORTED THE ENDOSCOPE RETAINER BAND BROKE DURING INSERTION OF THE DEVICE. NO ADDITIONAL DETAILS WERE PROVIDED BY THE CUSTOMER. THE DEVICE WAS SUCCESSFULLY AND UNEVENTFULLY REMOVED AND THE CASE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487100 ↗
• InjuryJul 11, 2016Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A SUCCESSFUL TIF AND HIATAL HERNIA PROCEDURE WAS COMPLETED. THE DAY AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH UNSPECIFIED SYMPTOMS. INDICATION OF LOW HEMATOCRIT ANEMIA AND HEMATOCHEZIA WAS NOTED AND THE PATIENT WAS GIVEN AN UNSPECIFIED AMOUNT OF BLOOD. AN EGD PROCEDURE WAS PERFORMED AND BLOOD WAS FOUND IN THE STOMACH ALONG WITH A HEMATOMA WITH EXTRAVASATED TISSUE. THE EXTRAVASATED TISSUE WAS SUCCESSFULLY CAUTERIZED.

  Patient problems: Anemia; Extravasation; Hematoma

  MAUDE report 5784375 ↗
• InjuryMar 15, 2016Adverse Event Without Identified Device or Use Problem

  THE COMPANY SALES REP REPORTED THAT IN AN EMAIL CORRESPONDENCE WITH THE PHYSICIAN, IT WAS MENTIONED THE TIF PATIENT, WHO WOULD NORMALLY SPEND ONE NIGHT IN THE HOSPITAL FOLLOWING THE PROCEDURE, HAD SPENT SEVERAL MORE DAYS DUE TO BLEEDING. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS DISCARDED BY THE HOSPITAL AFTER THE SUCCESSFUL PROCEDURE. BLEEDING WAS IDENTIFIED AFTER THE PATIENT WAS BACK IN HER ROOM. POST PROCEDURE EXAMS/TESTING SHOWED NO FURTHER BLEEDING AND NO SPECIFIC BLEEDER SITE WAS FOUND. THE BLEEDING RESOLVED ON ITS OWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5501638 ↗
• MalfunctionJan 14, 2016Break; Difficult to Insert; Physical Resistance

  SURGEON WAS IN THE INITIAL PROCESS OF INSERTING DEVICE DOWN THE PATIENT'S ESOPHAGUS. THE DEVICE WAS IN THE PROXIMAL ESOPHAGUS WHEN THE SURGEON EXPERIENCED SOME RESISTANCE IN PROGRESSING DOWN THE ESOPHAGUS. THE PHYSICIAN EXTRACTED THE DEVICE. FOLLOWING REMOVAL IT WAS NOTICED THE ELASTIC BAND WHICH HOLDS THE DISTAL TIP OF THE ENDOSCOPE IN PLACE AGAINST THE DISTAL TIP OF THE DEVICE DURING INSERTION WAS BROKEN. THERE WERE NO ADVERSE PATIENT EFFECTS AND A SECOND DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5368436 ↗