EsophyX Z R2006Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810275011072), received between Mar 15, 2016 and Nov 18, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A HIATAL HERNIA REPAIR PROCEDURE FOLLOWED BY A TIF PROCEDURE. NO ISSUES WERE NOTED DURING THE TIF PROCEDURE UNTIL THE FINAL STAGE OF DEVICE REMOVAL WHERE THE DEVICE BECAME CAUGHT ON THE BITE BLOCK. A BROKEN SMALL GRAY PIECE OF PLASTIC WAS FOUND IN PATIENT'S SOFT PALATE. THE DEVICE WAS REMOVED, AND THE BROKEN PIECE WAS UNEVENTFULLY AND SUCCESSFULLY RETRIEVED. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840803 ↗
• MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A TIF PROCEDURE, THE PHYSICIAN REPORTED THE DEVICE BECAME STUCK IN THE PATIENT'S THROAT DURING DEVICE REMOVAL. THE BAILOUT PROCEDURE IN THE PRODUCT IFU WAS PERFORMED AND THE RETRACTOR CABLE WAS ALSO CUT TO FACILITATE DEVICE PROXIMAL END (I.E. DEVICE HANDLE AND SHAFT) REMOVAL. THE DEVICE SHAFT WAS REMOVED FROM THE PATIENT. THE DISTAL END OF THE DEVICE REMAINED INSIDE THE PATIENT'S THROAT. AN ENT PHYSICIAN WAS CONTACTED AND THE DISTAL END WAS UNEVENTFULLY REMOVED THROUGH THE PATIENT'S MOUTH. A POST-PROCEDURE EGD WAS PERFORMED AND A 2-3CM LONG MUCOSAL TEAR WAS IDENTIFIED APPROXIMATELY 38CM FROM THE PATIENT'S INCISORS. THE PHYSICIAN TREATED THE MUCOSAL TEAR BY USING CLIPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Tissue Damage

  MAUDE report 9205696 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS ADMITTED TO THE HOSPITAL THE DAY AFTER A TIF PROCEDURE. THE ATTENDING PHYSICIAN STATED: "[THE] PATIENT WAS FOUND TO HAVE PNEUMOPERITONEUM, PNEUMOTHORAX, AND PLURAL EFFUSION TRACKING TO THE ESOPHAGUS RESULTING IN PROLONGED HOSPITALIZATION AND REQUIRING LEFT VATS AND DECORTICATION, PLEURX CATHETER INSERTION, AND THEN DEVELOPED BILATERAL PULMONARY EMBOLI." THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON AN UNKNOWN DATE.

  Patient problems: No Code Available; Pleural Effusion; Pneumothorax

  MAUDE report 8839292 ↗
• InjuryFeb 27, 2018Physical Resistance

  A HIATAL HERNIA REPAIR WAS PERFORMED CONCOMITANTLY TO A TIF PROCEDURE. WHILE INSERTING THE ESOPHYX Z DEVICE WITH A PEDIATRIC ENDOSCOPE, THE CUSTOMER NOTED THE ENDOSCOPE RETROFLEXED IN THE PATIENT'S ESOPHAGUS. THE DEVICE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT. THE CUSTOMER ATTEMPTED A SECOND INSERTION WITH THE ENDOSCOPE EXTENDED PAST THE END OF THE TISSUE MOLD APPROXIMATELY 1CM, WHEN RESISTANCE WAS ENCOUNTERED. THE DEVICE AND ENDOSCOPE WERE AGAIN REMOVED FROM THE PATIENT. AN EGD WAS THEN PERFORMED AND NOTHING WAS FOUND, THOUGH AN ESOPHAGEAL PERFORATION WAS SUSPECTED APPROXIMATELY BETWEEN 11-15CM FROM THE PATIENT'S INCISORS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY. A CT SCAN WITH CONTRAST WAS PERFORMED (B)(6) 2018 AND THE RESULTS WERE INTERPRETED AS A FULL THICKNESS ESOPHAGEAL PERFORATION. A THORACIC SURGEON PERFORMED AN EXPLORATORY SURGERY (B)(6) 2018 TO INSPECT THE ESOPHAGUS. NO PERFORATION WAS FOUND BUT A 4CM MEDIUM THICKNESS ESOPHAGEAL LACERATION WAS NOTED. THE THORACIC SURGEON LEFT A DRAIN AND NG TUBE IN THE PATIENT. THE PATIENT REMAINED IN THE HOSPITAL AS OF (B)(6) 2018.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 7301764 ↗
• InjuryApr 12, 2017Difficult to Remove; Sticking; Physical Resistance

  THE USER REPORTED SIGNIFICANT RESISTANCE WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT AT THE END OF THE PROCEDURE. THE ENDOSCOPE WAS ALSO UNABLE TO BE REMOVED FROM THE DEVICE. MORE LUBRICANT WAS ADDED TO THE DEVICE/ENDOSCOPE INTERFACE BUT THE ENDOSCOPE REMAINED UNABLE TO BE REMOVED. DURING THIS TIME, IT WAS REPORTED AN ORANGE COLOR WAS SEEN ON THE ENDOSCOPE MONITOR. A SECONDARY ENDOSCOPE WAS INSERTED AND OBSERVED THE DEVICE TISSUE MOLD STUCK 25-35 DEGREES FROM FULLY OPEN. THE FIRST ENDOSCOPE WAS ABLE TO BE PULLED BACK OUT OF THE TISSUE MOLD AFTER MANIPULATING THE ENDOSCOPE CONTROLS. THE DEVICE WAS THEN SUCCESSFULLY REMOVED FROM THE PATIENT. DURING THE POST-PROCEDURE EGD, A 2-3 CM LONG LACERATION WAS SEEN ON THE ESOPHAGUS LOCATED LATERALLY ABOVE THE GEJ (APPROXIMATELY 35-37 CM FROM THE MOUTH OF THE PATIENT). THE USER TREATED THE LACERATION WITH 3 ENDOCLIPS.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 6487127 ↗
• InjuryMar 15, 2016Leak/Splash

  A SUCCESSFUL TIF PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND THE DEVICE WAS DISPOSED OF PER HOSPITAL POLICY. TWO DAYS LATER THE PHYSICIAN REPORTED TO THE EGS SALES REPRESENTATIVE THE PATIENT WAS READMITTED WITH CHEST PAIN. IT WAS POSTULATED A SMALL LEAK DEVELOPED DURING THE PROCEDURE, ALLOWING PROCEDURE INSUFFLATION GAS INTO THE MEDIASTINUM. A CT SCAN SUPPORTED THIS AS IT DID NOT SHOW ANY ANY PLEURAL EFFUSION OR SUB-DIAPHRAGM AIR AND INDICATED ANY LEAK HAD RESOLVED ON ITS OWN. EXPERIENCE HAS SHOWN THE PROCEDURE GAS USED WILL ABSORB AFTER TWO TO THREE DAYS IN MOST CASES. THE PHYSICIAN TOOK A POSITION OF EXPECTANT SURVEILLANCE WITH NO INTERVENTION. A FEW DAYS LATER THE PHYSICIAN REPORTED THE PATIENT WAS DOING WELL. THE GAS HAD ABSORBED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Chest Pain

  MAUDE report 5502996 ↗