EsophyX Z+ R2007Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00810275011089), received between Apr 13, 2018 and Jun 5, 2026 — classified as 1 death, 50 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 14, 2025Open, Classified

   Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

   Z-1640-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY REVEALED A PATIENT WHO DEVELOPED ASPIRATION PNEUMONIA COMPLICATED BY FLASH PULMONARY EDEMA REQUIRING POST-PROCEDURE HOSPITALIZATION AND MEDICAL MANAGEMENT FOR FIVE DAYS FOLLOWING THE TIF PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pneumonia; Pulmonary Edema

  MAUDE report 25408787 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE CASE REPORT BY ABBASI ET AL. (B)(6) 2026) DESCRIBES A 39-YEAR-OLD MALE WHO DEVELOPED HEMODYNAMIC INSTABILITY AND MELENA TWO DAYS AFTER TRANSORAL INCISIONLESS FUNDOPLICATION USING THE ESOPHYX DEVICE. THE PATIENT REQUIRED INTRAVENOUS FLUIDS, TWO UNITS OF PACKED RED BLOOD CELLS, REPEAT ENDOSCOPY, CAUTERIZATION OF A FORREST IIA GASTRIC CARDIA ULCER, AND ADDITIONAL HEMOSTATIC CLIPS BEFORE RECOVERING.

  Patient problems: Hemodynamic instability; Melena

  MAUDE report 25398263 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE STUDY BY KEIHANIAN ET AL. (2026) RETROSPECTIVELY PROCEDURES PERFORMED USING THE ESOPHYX-Z DEVICE. ONE PATIENT DEVELOPED PERSISTENT ABDOMINAL PAIN AND WAS FOUND TO HAVE PNEUMOPERITONEUM ON COMPUTED TOMOGRAPHY WITHOUT EVIDENCE OF AN APPARENT LEAK. THE PATIENT WAS MANAGED CONSERVATIVELY.

  Patient problems: Abdominal Pain

  MAUDE report 25398251 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE ESOPHYX DEVICE PRODUCT FAMILY. THE STUDY BY HODGENS ET AL. (2025) THE AUTHORS REPORTED ONE INTRAOPERATIVE PROXIMAL ESOPHAGEAL PERFORATION, WHICH WAS MANAGED NONOPERATIVELY.

  Patient problems: Internal Organ Perforation

  MAUDE report 25398221 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A LITERATURE SEARCH FOR THE ESOPHYX DEVICE FAMILY WAS PERFORMED AND A STUDY, "TRANSORAL INCISIONLESS FUNDOPLICATION IN THE UNITED KINGDOM: INITIAL OUTCOMES AND LEARNING CURVE EXPERIENCE" BY NORTON ET AL. (2025), REPORTED ONE EVENT IN WHICH A PATIENT DEVELOPED AN ESOPHAGEAL PERFORATION WITH PERI-ESOPHAGEAL FLUID COLLECTION FOLLOWING USE OF THE ESOPHYX DEVICE. THE EVENT REQUIRED HOSPITAL ADMISSION AND TREATMENT WITH INTRAVENOUS ANTIBIOTICS.

  Patient problems: Perforation of Esophagus

  MAUDE report 25374833 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  CUSTOMER REPORTS AFTER INSERTING THE DEVICE AND CONFIRMING THE POSITION, THEY WENT TO SCREW IN THE HELIX. AFTER APPROXIMATELY TWO TO THREE TURNS, THE HELIX ANCHOR WAS DETACHED FROM THE WIRE. THIS RESULTED IN THEM HAVING TO REMOVE THE DEVICE, OPEN A SECOND KIT AND RETRIEVE THE DETACHED ANCHOR IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645284 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THE PHYSICIANS SUCCESSFULLY PERFORMED A CONCOMITANT HIATAL HERNIA REPAIR WITH ENDOSCOPIC FUNDOPLICATION (CTIF) ON (B)(6) 2024 WITHOUT COMPLICATIONS. NO MEDICAL DEVICE MALFUNCTION NOTED. APPROXIMATELY 13 DAYS LATER, THE PATIENT RETURNED TO MEDICAL CENTER REPORTING CHEST PAIN. A CT SCAN IN THE EMERGENCY DEPARTMENT REVEALED A SUSPECTED ABSCESS, LIKELY CAUSED BY A LEAK AT THE GASTROESOPHAGEAL JUNCTION. THE PHYSICIAN SUCCESSFULLY DRAINED THE ABSCESS. MESH HAD BEEN PLACED DURING THE INITIAL PROCEDURE, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. THE PATIENT WAS ADMITTED AND WAS DISCHARGED ON (B)(6) 2024 IN STABLE CONDITION.

  Patient problems: Abscess; Bacterial Infection; Chest Pain; Perforation of Esophagus

  MAUDE report 20258277 ↗
• MalfunctionAug 28, 2024Loss of or Failure to Bond; Mechanical Problem; Retraction Problem; Use of Device Problem; Loss of or Failure to Bond; Mechanical Problem; Retraction Problem; Use of Device Problem

  A PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. THROUGHOUT THE TIF PROCEDURE, THE PHYSICIAN REPORTED ISSUES WHEN DELIVERING FASTENERS FROM THE ESOPHYX DEVICE AND TROUBLESHOOTED THE PROBLEM. ONE STYLET WAS REPORTEDLY OUTSIDE OF THE GRAY MOLDING AND WOULD NOT RETRACT. THE ESOPHYX DEVICE WAS UNEVENTFULLY REMOVED FORM THE PATIENT. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091463 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT UNDERWENT A HIATIAL HERNIA REPAIR [HH] AND TRANSORAL INCISIONLESS FUNDOPLICATION [CTIF] PROCEDURE. A 60F BOUGIE WAS USED TO STREACH THE ESOPHAGUS PRIOR TO HH REPAIR. THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE DUE TO BACK PAIN AND A FEVER. FOLLOWING ADMITTANCE, THE PT RECEIVED AN EGD WITH NO NOTED ISSUES ON AN UNKNOWN DATE, AND CT SCAN WITH BARIUM SWALLOW ON AN UNKNOWN DATE. THE PT WAS SUBSEQUENTLY DIAGNOSED WITH A LEAK FROM AN UNKNOWN AREA WITH FLUID COLLECTION BEING DETECTED NEAR THE LIVER. THE PHYSICIAN ALLEGES THAT THERE IS NO EVIDENCE OF PERFORATION NEAR THE SITE OF THE TIF. (B)(6) 2023, THE PHYSICIAN PLACED A DRAIN FOR FLUID COLLECTION. THE CAUSE OF THE FLUID COLLECTION IS UNKNOWN. THE DEVICE WAS DISCARDED AT THE FACILITY WITH NO ADDITION PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Perforation

  MAUDE report 20082527 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REPORTEDLY EXPERIENCED AN ADVERSE EVENT(S) FOLLOWING A HIATAL HERNIA REPAIR (HHR) AND TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE A PATIENT WAS ADMITTED FOR TWO ADDITIONAL DAYS FOR SURGICAL INTERVENTION TO CONTROL INTERNAL BLEEDING AND DEPLOYED HEMOSTATIC AGENTS FOR A NOTED HEMATOMA. THE PATIENT RECEIVED A BLOOD 1 UNIT OF BLOOD AND WAS CLOSELY MONITORED DURING RECOVERY. THE PATIENT WAS DISCHARGED 8 DAYS LATER WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20082526 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A MALE PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION [TIF] PROCEDURE FOR GERD. THE PATIENT HAD A SEVERE COUGH, THAT WAS UNRELATED TO THE PROCEDURE WHEN DISCHARGED FROM THE HOSPITAL. THE PATIENT PRESENTED AGAIN 11 DAYS POST-TIF PROCEDURE FOR A GI PERFORATION ON THE ANTERIOR SIDE OF THE FASTENERS. IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE FASTENER FAILURES OR THE ALLEGED GI PERFORATION. THE CHEST TUBES WERE ALSO PLACED IN THIS PATIENT TO PREVENT IMPAIRMENT. THE DEVICE WAS NOT RETURNED FOR ENGINEERING OBSERVATION AND THERE ARE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PATIENT TOLERATED THE PROCEDURES AND INTERVENTIONS WELL.

  Patient problems: Perforation of Esophagus; Pleural Empyema

  MAUDE report 20081883 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLUTATION [TIF] PROCEDURE AND WAS DISCHARGED TO HOME WITH NO PATIENT SYMPTOMS. THE PATIENT RETURNED TO THE HOSPITAL AT A LATER DATE AND WAS DIAGNOSED WITH ORTHOSTATIC HYPOTENSION. THE PATIENT'S HEMATOCRIT WAS ALSO LOW AFTER BLOOD TESTING. AN UPPER ENDOSCOPY WAS COMPLETED AND BLOOD WAS IDENTIFIED IN THE PATIENT'S STOMACH. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. NO INTERVENTIONS WERE DEEMED NECESSARY. APRIL 12, 2023, THE PATIENT WAS DOING FINE AND IS RECOVERING WELL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20052078 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  YOUTUBE VIDEO COMPLAINT WAS RECEIVED BY THE EGS TEAM. THE ACCOUNT ALLEGES THE PATIENT UNDERWENT A SUCCESSFUL HIATIAL HERNIA REPAIR [HHR] AND TRANSORAL INCISIONLESS FUNDOPLUTATION [TIF] PROCEDURE. AN UPPER ENDOSCOPY WAS COMPLETED AFTER THE PROCEDURE AND BLOOD WAS LEAKING INTO THE PATIENT'S STOMACH. THE PATIENT WAS ADMITTED TO ICU FOR CONTINUED OBSERVATION, AN ADDITIONAL INTERVENTIONAL PROCEDURE TO CONTROL THE BLEEDING WAS DEEMED NECESSARY. THE PATIENT ALSO NEEDED A BLOOD TRANSFUSION POST-INTERVENTION. ACCORDING TO THE VIDEO, THE PATIENT IS RECOVERING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20049394 ↗
• InjuryAug 22, 2024Fluid/Blood Leak; Mechanical Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Optical Obstruction; Fluid/Blood Leak; Mechanical Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Optical Obstruction

  A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. AT LEAST ONE BOUGIE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. DURING THE TIF PROCEDURE, PER THE PHYSICIAN, THERE WAS DIFFICULTY DISENGAGING THE HELIX FROM TISSUE AT ONE PLACEMENT SITE. ONCE THE HELIX WAS DISENGAGED FROM THE TISSUE AT THE PLACEMENT SITE, SOME TISSUE WAS NOTED REMAINING IN THE HELIX COIL AND A BLEED, NOT REQUIRING TRANSFUSION WAS NOTED AT THE HELIX PLACEMENT SITE. THE PHYSICIAN ATTEMPTED TO CONTINUE THE PROCEDURE AND NOTED DIFFICULTY ENGAGING THE HELIX AT OTHER PLACEMENT SITES WITH THE NOTED TISSUE REMAINING IN THE COIL. ADDITIONALLY, THE PHYSICIAN NOTED IMPACTS TO VISIBILITY DUE TO THE BLEED AND DECIDED TO REMOVE THE ESOPHYX DEVICE. THE PHYSICIAN INSERTED AN ENDOSCOPE AND INJECTED EPINEPHRINE AT THE BLEEDING SITE. ADDITIONALLY, SEVEN HEMOSTATIC CLIPS WERE PLACED NEAR THE BLEEDING SITE, HOWEVER THE NOTED BLEEDING CONTINUED. PURA-STAT WAS APPLIED TO THE DISTAL ESOPHAGUS AT THE Z-LINE AND A COVERED ESOPHAGEAL STENT WAS PLACED IN THE DISTAL ESOPHAGUS. PER THE PHYSICIAN, THERE MAY HAVE BEEN MUSCULARIS TISSUE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20042259 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A SUCCESSFUL TRANSORAL INCISIONLESS FUND OPLUTATION [TIF] PROCEDURE. THE FOLLOWING DAY THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS AND A DROP IN HEMOGLOBIN. AN ESOPHAGOGASTRODUODENOSCOPY [EGD] WAS PERFORMED DEMONSTRATING A GASTROESOPHAGEAL BLEED AT ONE OF THE PLACEMENT SITES OF THE HELICAL RETRACTOR WHICH WAS REPORTED TO BE REMOVED WITHOUT PROPER DISENGAGEMENT. THE PHYSICIAN PLACED MULTIPLE CLIPS AT THE PLACEMENT SITE AND WAS ABLE TO CONTROL THE PATIENT'S BLEEDING. THE BLEEDING DID NOT REQUIRE A BLOOD TRANSFUSION FOR THIS PATIENT. ON (B)(6) 2023 THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20012717 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. BOTH PROCEDURES WERE COMPLETED, AND THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE AND WAS ADMITTED DUE TO INABILITY TO KEEP FOOD OR LIQUID DOWN. THE PATIENT UNDERWENT A CT SCAN ON (B)(6) 2024 WHICH DID NOT REVEAL A PERFORATION OR LEAK. FOLLOWING THE CT SCAN, A MEDIASTINAL DRAIN WAS PLACED ON (B)(6) 2024 AND A LEAK WAS CONFIRMED. AFTER THE DRAIN PLACEMENT AND LEAK CONFIRMATION, THE PATIENT UNDERWENT A SURGICAL PROCEDURE BY THE HHR PHYSICIAN ON AN UNKNOWN DATE TO DETECT ANY ABNORMALITIES. NO ABNORMALITIES WERE NOTED. ON (B)(6) 2024, THE PATIENT WAS STILL REPORTEDLY UNABLE TO KEEP FOOD OR LIQUID DOWN. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EDG) BY THE TIF PHYSICIAN AND WAS DIAGNOSED WITH A PERFORATION AND ESOPHAGEAL FISTULA. CLIPS WERE PLACED ENDOSCOPICALLY TO CLOSE THE FISTULA. FOLLOWING THE PLACEMENT OF CLIPS THE PATIENT WAS ABLE TO KEEP FOOD AND LIQUID DOWN. ADDITIONALLY, CULTURES WHICH WERE COMPLETED ON (B)(6) 2024 SHOWED CANDIDA FUNGUS. THUS, THE PT WAS PLACED ON

  Patient problems: Fistula; Fungal Infection; Perforation

  MAUDE report 19638633 ↗
• InjuryJun 24, 2024Contamination; Biocompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Contamination; Biocompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PRIOR TO THE TIF PROCEDURE THE PATIENT WAS NOTED TO HAVE HAD A CONSISTENT HICCUP FOR ONE YEAR PRECEDING THE TIF PROCEDURE. ADDITIONALLY, THE PATIENT WAS NOTED TO HAVE GRADE C ESOPHAGITIS WHICH IS A CONTRAINDICATION FOR THE TIF PROCEDURE. THE PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED LAPAROSCOPICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). FOLLOWING THE CTIF PROCEDURE, THE PATIENT WAS EXPERIENCING PAIN AND WAS KEPT FOR OBSERVATION. DESPITE THE CONTINUED PAIN, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER FIVE DAYS FOLLOWING THE HHR AND TIF PROCEDURES. THE PATIENT CONTINUED TO EXPERIENCE THE SAME PAIN NOTED IMMEDIATELY POST CTIF, VISITED, AND WAS ADMITTED TO A SECOND MEDICAL FACILITY (ADMISSION DATE UNKNOWN). ADDITIONALLY, AT THE SECOND MEDICAL FACILITY, THE PATIENT WAS RETCHING AND THE HICCUPS PERSISTED. THE PATIENT UNDERWENT A CT SCAN ON AN UNKNOWN DATE AND WAS DIAGNOSED WITH AN ABSCESS.

  Patient problems: Abscess

  MAUDE report 19602150 ↗
• InjuryJun 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. AT LEAST ONE BOUGIE WAS USED TO DILATE THE ESOPHAGUS PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE. FOLLOWING AN UNKNOWN SPAN OF TIME POST-TIF PROCEDURE, THE PATIENT WAS ADMITTED ON AN UNKNOWN DATE TO THE INTENSIVE CARE UNIT, DIAGNOSED WITH A PLEURAL EFFUSION, AND UNDERWENT VIDEO-ASSISTED THORACIC SURGERY (VATS) ON (B)(6) 2024. AS OF (B)(6) 2024, THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Pleural Effusion

  MAUDE report 19441929 ↗
• MalfunctionJun 1, 2024Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). THROUGHOUT THE TIF PROCEDURE, THE PHYSICIAN REPORTED ISSUES WHEN DELIVERING FASTENERS FROM THE ESOPHYX DEVICE. THE INITIAL ESOPHYX DEVICE WAS UNEVENTFULLY REMOVED FROM THE PATIENT AND THE TIF PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ESOPHYX DEVICE. THERE IS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441922 ↗
• InjuryMay 17, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE, CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED. PRIOR TO INSERTION OF THE ESOPHYX DEVICE, THE HELICAL RETRACTOR WAS REPORTEDLY PROPERLY STOWED AND LOCKED. AT AN UNKNOWN TIME DURING DEVICE INSERTION, THE HELICAL RETRACTOR MOVED FROM THE STOWED POSITION AND CAUSED A SUPERFICIAL MUCOSAL TEAR. THE DEVICE WAS UNEVENTFULLY REMOVED AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE PATIENT WAS DIAGNOSED WITH A MUCOSAL TEAR . THE PHYSICIAN PLACED CLIPS TO TREAT THE REPORTED MUCOSAL TEAR . AN ESOPHAGRAM WAS PLANNED TO BE PERFORMED ON (B)(6) 2024.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19347059 ↗
• InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A CTIF PROCEDURE CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE, CONDUCTED LAPAROSCOPICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE 56FR BOUGIE WAS INSERTED TO DILATE THE PATIENT'S ESOPHAGUS, AND NO ISSUES WERE NOTED DURING THE SUBSEQUENT PRE-TIF EGD. A SECOND BOUGIE (60FR MOLONEY) WAS THEN USED TO DILATE THE PATIENT'S ESOPHAGUS. THE TIF PROCEDURE WAS INITIATED AND WAS STARTED IN THE ANTERIOR POSITION AS THE POSTERIOR POSITION WAS NOTED AS "COLLAPSED DOWN". A "NORMAL" AMOUNT OF BLEEDING WAS NOTED AFTER THE SECOND FASTENER DELIVERY IN THE GREATER CURVE. THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED AND THE ESOPHYX DEVICE WAS REMOVED FROM THE PATIENT. DURING THE POST-TIF PROCEDURE EGD, BLOOD WAS NOTED FROM A LOCATION ABOVE WHERE FASTENERS WERE DELIVERED CLOSER TO THE LESSER CURVE. THE TIF PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PLACE CLIPS ENDOSCOPICALLY TO TREAT THE PERFORATION. LAPAROSCOPICALLY, THE PERFORATION WAS UNABLE TO BE LOCATED BY THE HHR PHYSICIAN AND AN INCISION WAS MADE BY THE TIF PHYSICIAN IN THE PATIENT'S STOMACH AND A STAPLE WAS PLACED AT THE SITE OF THE PERFORATION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19347058 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE, CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED. ON THE NEXT DAY FOLLOWING THE PROCEDURES, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF SHORTNESS OF BREATH AND WAS ADMITTED. THE PATIENT UNDERWENT BLOODWORK AND A CT SCAN ON AN UNKNOWN DATE AND WAS DIAGNOSED WITH A PULMONARY EMBOLISM. ANTICOAGULANT MEDICATION WAS ADMINISTERED. THE PATIENT WAS DISCHARGED ON AN UNKNOWN DATE.

  Patient problems: Pulmonary Embolism

  MAUDE report 19084349 ↗
• InjuryMar 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE BOUGIE WITH A GUIDEWIRE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. DURING THE PRE-TIF ESOPHAGOGASTRODUODENOSCOPY (EGD), PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE, AN ESOPHAGEAL TEAR WAS NOTED AT THE DISTAL ESOPHAGUS. THE PHYSICIAN PROCEEDED WITH THE TIF PROCEDURE, DESPITE THE NOTED TEAR, AND UNEVENTFULLY COMPLETED THE TIF PROCEDURE. DURING THE POST-TIF EGD, THE PREVIOUSLY NOTED ESOPHAGEAL TEAR WAS NOW NOTED AS AN ESOPHAGEAL PERFORATION. IT WAS ALSO NOTED THAT THREE ANTERIOR FASTENERS HAD BEEN TORN OUT; THE FASTENERS WERE STILL IN THE STOMACH BUT HAD PULLED OUT OF THE ESOPHAGUS. THE PHYSICIAN PLACED SUTURES AT THE SITE OF THE PERFORATION, AND A DRAIN WAS PLACED INTRA-ABDOMINALLY. THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT WAS EXTUBATED, A CHEST TUBE WAS PLACED, AND THE PATIENT WAS RE-INTUBATED. ON OF (B)(6) 2024, THE PATIENT UNDERWENT AN EGD, AND THE NOTED PERFORATION IS STILL LEAKING. AS OF (B)(6) 2024, THE PATIE

  Patient problems: Laceration(s) of Esophagus; Perforation of Esophagus; Respiratory Failure

  MAUDE report 18918841 ↗
• InjuryMar 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE BOUGIE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. THE TIF PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE AND WAS HELD FOR OBSERVATION COMPLAINING OF AN INABILITY TO KEEP FOOD AND LIQUIDS DOWN. THE PATIENT WAS INITIALLY SEEN BY AN ER PHYSICIAN AND UNDERWENT A BARIUM ESOPHAGRAM. THE PATIENT WAS LATER SEEN BY THE TIF PHYSICIAN AND DIAGNOSED WITH DYSPHAGIA. FOLLOWING THE TIF PHYSICIAN'S EVALUATION AND PATIENT'S OVERNIGHT STAY FOR OBSERVATION, THE ER PHYSICIAN CONFIRMED THE PATIENT WAS ABLE TO SWALLOW, KEEP FOOD AND LIQUID DOWN, AND THE DYSPHASIA SYMPTOMS HAD RESOLVED. AS OF (B)(6) 2024, THE PATIENT WAS RELEASED FROM THE HOSPITAL.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18918839 ↗
• DeathJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). PER THE PHYSICIAN, THE TIF PROCEDURE WAS COMPLETED UNEVENTFULLY AND THE ESOPHYX DEVICE PERFORMED AS INTENDED. FOLLOWING BOTH PROCEDURES, THE PATIENT REMAINED IN THE HOSPITAL AND WAS DIAGNOSED WITH CORONARY ARTERY DISEASE, ESOPHAGEAL ISCHEMIA, AND AN ESOPHAGEAL PERFORATION DURING HOSPITALIZATION. THE PATIENT UNDERWENT A CT SCAN, BARIUM SWALLOW, AND AN ESOPHAGRAM ON UNKNOWN DATES. AN ENDOSCOPY WAS PERFORMED ON AN UNKNOWN DATE TO REPAIR THE ESOPHAGEAL PERFORATION AND TO PLACE A STENT AND CHEST TUBE. PER THE PHYSICIAN, THE PATIENT PASSED AWAY SOMETIME BETWEEN (B)(6) 2023 AND (B)(6) 2023.

  Patient problems: Ischemia; Perforation of Esophagus; Pleural Empyema

  MAUDE report 18553327 ↗