SerosaFuse® Implantable Fastener Kit R2275Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00810275014011), received between Sep 11, 2024 and Jun 24, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 18, 2026.

Recalls naming this device

1. Mar 14, 2025Class IIOpen, Classified

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

   Z-1641-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  A MEDWATCH WAS RECEIVED REPORTING AN EVENT WITH A MERIT ESOPHYX DEVICE. IT WAS REPORTED THAT DURING A TIF (TRANSORAL INCISIONLESS FUNDOPLICATION) PROCEDURE (TRANSOESOPHAGEAL INCISION LESS FUNDOPLICATION) FOR GERD AND ESOPHAGITIS. NO HERNIA NOTED. THE ESOPHYX 2 (HD) DEVICE IMPLANTED. SYMPTOMS WORSENED. EGD (ESOPHAGOGASTRODUODENOSCOPY) SHOWED A MEDIUM HIATAL HERNIA WITH TIF SURGICAL WRAP INSIDE HERNIA. SURGERY INCARCERATED TYPE 2 PARA ESOPHAGEAL HERNIA WITH GE (GASTROESOPHAGEAL) JUNCTION AND STOMACH IN MEDIASTINUM. EXTENSIVE DISSECTION. TIF SCARRED AND LEFT IN. "ON (B)(6) 2023, I HAD A TIF (TRANSORAL INCISIONLESS FUNDOPLICATION) PROCEDURE (TRANSESOPHAGEAL INCISIONLESS FUNDOPLICATION) FOR GERD AND ESOPHAGITIS. NO HERNIA NOTED. ESOPHYX 2 (HD) DEVICE IMPLANTED. SYMPTOMS WORSENED. EGD(ESOPHAGOGASTRODUODENOSCOPY) (B)(6) 2026, MEDIUM HIATAL HERNIA WITH TIF SURGICAL WRAP INSIDE HERNIA. SURGERY (B)(6) 2026, INCARCERATED TYPE 2 PARA ESOPHAGEAL HERNIA WITH GE (GASTROESOPHAGEAL) JUNCTION AND STOMACH IN MEDIASTINUM. EXTENSIVE DISSECTION. TIF SCARRED AND LEFT IN."

  Patient problems: Hernia; Vascular Dissection

  MAUDE report 25611478 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ROBOTIC HIATAL HERNIA REPAIR USING THE MERIT SEROSAFUSE®, OLYMPUS H190 ADULT UPPER ENDOSCOPE AND TOWER, AND DAVINCI INSUFFLATOR SHOWED EVIDENCE OF A LEAK AT THE GASTROESOPHAGEAL JUNCTION (GEJ) ON BARIUM WITH CONTRAST STUDY, ONE WEEK AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 25233220 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER ALLEGED A TRANSORAL INCISIONLESS FUNDOPLICATION (CTIF) AND HIATAL HERNIA REPAIR WAS COMPLETED ON (B)(6) 2025 WITHOUT INCIDENT AND THE PATIENT WENT HOME THE NEXT MORNING. THE PATIENT RE-ENTERED THE HOSPITAL IN THE ICU ON (B)(6) 2026 AS SHE WAS BECOMING SEPTIC. ON (B)(6) 2026 THE PATIENT HAD EPIGASTRIC PAIN AND AN ELEVATED WHITE CELL COUNT. ON THE EVENING OF (B)(6) 2026, A CTA OF THE PATIENTS' CHEST CONFIRMED BILATERAL PLURAL EFFUSIONS, IDENTIFYING A "LEAK/PERFORATION". A RIGHT CHEST TUBE WAS THEN PLACED AND AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED CONFIRMING A PROXIMAL PERFORATION TO THE GASTROESOPHAGEAL JUNCTION. A COVERED STENT WAS PLACED TO SEAL THE INJURY AND STABILIZE THE PATIENT. THE PERFORATION ITSELF WAS IN THE AREA OF THE SEROSAFUSE FASTENERS, PLACED BY THE ESOPHYX DEVICE.

  Patient problems: Internal Organ Perforation

  MAUDE report 24066480 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ACCOUNT ALLEGES THAT A HH REPAIR TOOK PLACE FOLLOWED BY TIF. AFTER THE 14TH SEROFUSE FASTENER WAS PLACED, A SMALL HOLE WAS NOTICED IN THE STOMACH ANTERIORLY. IT IS UNCLEAR IF THE PERFORATION WAS CAUSED DURING THE HH REPAIR OR TIF. THEY THEN CLIPPED THE PERFORATION ENDOSCOPICALLY AND SUTURED THE PERFORATION FROM THE ABDOMINAL CAVITY. A VIEW WAS THEN TAKEN FROM THE ABDOMINAL CAVITY VIA DAVINCI AND ENDOSCOPICALLY SIMULTANEOUSLY TO ENSURE THE PERFORATIONS WAS SEALED.

  Patient problems: Internal Organ Perforation

  MAUDE report 23816105 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A CONCOMITANT TRANSORAL INCISIONLESS FUNDOPLICATION (CTIF) PROCEDURE, THE PHYSICIAN ELECTED TO ABORT THE PROCEDURE PRIOR TO COMPLETION. AFTER PLACEMENT OF TWELVE FASTENERS TO SECURE THE ANTERIOR AND POSTERIOR CORNERS OF THE FUNDOPLICATION WRAP, THE PHYSICIAN NOTED A LOSS OF INSUFFLATION. UPON INSPECTION AWAY FROM THE ESOPHAGOGASTRIC (EG) JUNCTION AND INTO THE GASTRIC WALL AREA, THE PHYSICIAN OBSERVED WHAT APPEARED TO BE A TEAR IN THE STOMACH WALL. THE PHYSICIAN SUBSEQUENTLY APPLIED NINE ENDOSCOPIC CLIPS TO CLOSE THE SUSPECTED TEAR AFTER THE MERIT MEDICAL DEVICE WAS REMOVED FROM THE PATIENT. NO ADDITIONAL FASTENERS WERE DEPLOYED, AND THE CASE WAS CONCLUDED AT THAT POINT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23405385 ↗
• InjuryAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES A PATIENT ENTERED THE ER 6 DAYS POST-OP ON (B)(6) 2025 WITH ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. CT SCAN SAME DAY SHOWED APPROXIMATELY 2X2CM COLLECTION OF AIR AND ORAL CONTRAST PROXIMAL TO GEJ IN ABDOMEN, THEY NOTED CONCERN FOR CONTAINED ESOPHAGEAL PERFORATION. THE PATIENT WAS PLACED ON PAIN MEDS, ABX AND ANTIFUNGAL. THE PATIENT REQUIRED 3 UNITS OF BLOOD TRANSFUSED. THEY PERFORMED EGD ON (B)(6), FOUND BLEEDING IN STOMACH, CLOSE TO GEJ THOUGH EXACT SOURCE OF BLEEDING WAS INDETERMINATE. ENDOCLOT POWDER WAS SPREAD OVER GEFV. STENT WAS PLACED ACROSS GEJ. SUBSEQUENT CT SCAN ORDERED SHOWED 2.6X2.3CM COLLECTION OF AIR AND ORAL CONTRAST IN ABDOMEN PROXIMAL TO GEJ IN ABDOMEN, BLEEDING IN THE ANTERIOR LESSER CURVATURE OF THE STOMACH, AND NOTED A SMALL PLEURAL EFFUSION. 2ND EGD SHOWED STENT HAD MIGRATED AND IT WAS SUBSEQUENTLY REMOVED. CAUTERY WAS USED ON THE LIP OF THE GEFV AT APPROXIMATELY THE 5 O'CLOCK LOCATION WHERE BLEEDING WAS NOTED, CLIP WAS PLACED IN THIS LOCATION. THEY HAVE CHARACTERIZED THIS AS A LEAK AT THE GEJ - THEORIZING THE SMALL LEAK WAS ALONG THE PATH OF A SEROSA FUSE FASTENER - AND NOT DUE TO AN ESOPHAGEAL PERFORATION. NO ADDITIONAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810243 ↗
• MalfunctionMay 22, 2025Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THE HELIX DEVICE WAS STUCK INSIDE OF THE CHANNEL. THIS FAILURE TOOK PLACE TOWARDS THE END OF THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072770 ↗
• MalfunctionMay 22, 2025Difficult to Insert; Difficult to Insert

  THE ACCOUNT ALLEGES WHILE PREPARING THE DEVICE ON THE BACK TABLE, THE ESOPHYX DEVICE WOULD NOT LOAD FASTENERS ONTO THE WIRE. THE DEVICE WAS EXCHANGED AND THE TIF PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072762 ↗
• InjuryMay 22, 2025Difficult to Advance; Difficult to Advance

  THE ACCOUNT ALLEGES THAT ON (B)(6) 2025, A PHARYNGEAL PERFORATION [GI PERFORATION] WAS NOTED POST CTIF PROCEDURE ON A FEMALE PATIENT. THE MERIT REP WAS NOTIFIED OF THIS EVENT ON 4/27/25. A ROBOTIC HIATAL HERNIA REPAIR WAS PERFORMED BY GS DR. (B)(6). THIS PATIENT HAD A PRIOR TOUPET FUNDOPLICATION [PARTIAL FUNDOPLICATION], WHICH DR. (B)(6) TOOK DOWN AND REPAIRED ALONG WITH THE RECURRENT HIATAL HERNIA. THE GI PHYSICIAN, (B)(6) THEN FOLLOWED UP WITH AN INITIAL EGD. A SMALL TEAR IN THE UPPER ESOPHAGUS NEAR THE GLOTTIS WAS APPRECIATED, JUST ADJACENT TO THE PATIENT'S ET TUBE. IT APPEARED TO DR. (B)(6) THAT THE GI TEAR HAD BEEN CAUSED BY THE ANESTHESIA TEAM DURING PLACEMENT OF THE ET TUBE. ESOPHAGEAL WEBBING AND 2 TWISTING BANDS OF TISSUE WERE ALSO NOTED IN THE MID-ESOPHAGUS, AS WELL AS A SOMEWHAT TORTUOUS DISTAL ESOPHAGUS. AN ESOPHAGEAL BALLOON DILATION WAS THEN PERFORMED WITHOUT INCIDENT. DR. (B)(6) DECIDED TO CAUTIOUSLY PROCEED WITH THE PLACEMENT OF THE ESOPHYX DEVICE FOR THE SCHEDULED TIF PROCEDURE. THE ESOPHYX DEVICE WAS PREPPED ON THE BACK TABLE. THE INSIDE WAS LUBRICATED WITH MINERAL OIL; THE OUTSIDE WAS LUBRICATED WITH A GENEROUS AMOUNT OF SURGICAL LUBRICANT. A JAW THRUST TECHNIQUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072740 ↗
• MalfunctionApr 2, 2025Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; No Apparent Adverse Event; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; No Apparent Adverse Event

  THE CUSTOMER REPORTS THAT DURING A TIF PROCEDURE, AFTER PLACEMENT OF THE THIRD FASTENER, THE PHYSICIAN ATTEMPTED TO RETRACT THE HELICAL RETRACTOR SO HE COULD SAFELY REMOVE THE DEVICE FROM THE PATIENT. THE HELICAL RETRACTOR WAS BENT AND BECAME STUCK AT THE END OF THE DEVICE AFTER FULL RETRACTION. THE DEVICE WAS EVENTUALLY REMOVED FROM THE PATIENT, AND A SECOND DEVICE WAS USED TO COMPLETE THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755155 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A CER LITERATURE SEARCH WAS CONDUCTED FOR AN ESOPHAGEAL DEVICE USED TO TREAT GASTROESOPHAGEAL REFLUX DISEASE (GERD). DURING THE TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, AN ESOPHAGEAL MUCOSAL TEAR OCCURRED IN THE PATIENT REQUIRING CLOSURE VIA 4 ENDOSCOPIC HEMOCLIPS AFTER THE SUCCESSFUL COMPLETION OF THE PRIMARY TIF PROCEDURE. DURING A FOLLOW-UP APPOINTMENT THREE DAYS LATER, A CT STUDY WAS ORDERED DEMONSTRATING ESOPHAGEAL INFLAMMATION WITHIN THE PATIENT. THE PATIENT WAS READMITTED TO THE HEALTHCARE FACILITY AND WAS TREATED WITH IV ANTIBIOTICS. THE PATIENT WAS DISCHARGED TWO DAYS LATER.

  Patient problems: Inflammation; Laceration(s) of Esophagus

  MAUDE report 21425366 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 22, 2025, A CER LITERATURE SEARCH WAS CONDUCTED FOR AN ESOPHAGEAL DEVICE USED TO TREAT GASTROESOPHAGEAL REFLUX DISEASE (GERD). POST-TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE (24 HOURS), THE PATIENT EXPERIENCED AN UPPER GASTROINTESTINAL BLEED, AND AN ILEUS DEVELOPED. THIS PATIENT WAS SUCCESSFULLY MANAGED CONSERVATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Gastrointestinal Hemorrhage; Unspecified Gastrointestinal Problem

  MAUDE report 21425352 ↗
• InjuryFeb 13, 2025Material Fragmentation; Material Separation; Difficult to Open or Close; Mechanical Jam; Material Fragmentation; Material Separation; Difficult to Open or Close; Mechanical Jam

  THE ACCOUNT ALLEGES THAT HAD A TIF PROCEDURE FOLLOWING A HIATAL HERNIA [HH] REPAIR. UPON COMPLETION OF THE TIF PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT. WHEN HE TRIED TO PULL THE DEVICE OUT, THE TISSUE MOLD WOULDN'T OPEN PROPERLY, ALMOST LIKE IT WAS STUCK OR JAMMED. HE GENTLY TWISTED THE DEVICE AND SCOPE AND ANESTHESIA ASSISTED WITH A JAW THRUST AND THE DEVICE WAS EVENTUALLY ABLE TO BE REMOVED. THERE WERE PIECES OF THE TISSUE MOLD (THE CHASSEY) THAT CAME APART AND HAD TO BE RETRIEVED FROM THE PATIENT. THERE WERE MINOR MUCOSAL TEARS, BUT THE DOCTOR WASN'T CONCERNED AND SAID THE PATIENT WAS FINE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21379202 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST-TIF PROCEDURE, THE PATIENT WAS EXPERIENCING SOME INTERNAL BLEEDING. THE PHYSICIAN USED A PAIR OF HEMOSTATS, A CAUTERIZATION CATHETER, MEDICATIONS, AND A GI CLIP TO STOP THE BLEEDING BEFORE MOVING THE PATIENT TO RECOVERY. THE PHYSICIAN THINKS THE DAMAGE MAY HAVE BEEN CAUSED BY THE HELICAL RETRACTOR THAT WAS DEPLOYED WITHIN THE PATIENT'S GI TISSUE TO FORM FUNDOPLICATION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO DEVICE MALFUNCTION TO REPORT. THE DEVICE OPERATED AS INTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21129218 ↗
• InjuryJan 10, 2025Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  THE CUSTOMER REPORTS THAT SEVERAL DAYS POST-TIF PROCEDURE, THE PHYSICIAN NOTICED A FEMALE IN-PATIENT'S BLOOD PRESSURE WAS ELEVATED. THE PHYSICIAN PERFORMED ADDITIONAL TESTS INCLUDING A CT SCAN AND AN ENDOSCOPY, AND NOTHING SEEMED ABNORMAL AT THE TIME. THE PHYSICIAN DECIDED TO BRING THE PATIENT BACK TO SURGERY TO SEE IF HE COULD IDENTIFY A SUSPECTED FLUID LEAK. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE ABDOMEN WAS FILLED WITH GASTRIC JUICE, AND GI BUBBLING WAS IDENTIFIED ALONG THE FASTENER LINE. THE PHYSICIAN DEPLOYED A SELF-EXPANDABLE STENT FOR ADDITIONAL SUPPORT ON (B)(6) 2024 AND THE GASTRIC MUCOSA LEAK WAS SUCCESSFULLY CAUTERIZED. THE PHYSICIAN STATES THAT THE TRANSORAL RECONSTRUCTIVE DEVICE AND THE FASTENER CARTRIDGE BOTH PERFORMED AS INTENDED. NO DEVICE MALFUNCTIONS WERE NOTED DURING THIS PROCEDURE. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE GASTRIC MUCOSA LEAK. THE PATIENT HAS FULLY RECOVERED AND TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Fluid Discharge; High Blood Pressure/ Hypertension; Perforation of Esophagus

  MAUDE report 21129208 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A 35-YEAR-OLD MALE PATIENT HAD HIATAL HERNIA REPAIR FOLLOWED BY A SUCCESSFUL TIF PROCEDURE. THE NEXT DAY, THE PATIENT WAS COMPLAINING OF ABDOMINAL PAIN. THE PHYSICIAN PERFORMED A CT SCAN WITH CONTRAST. THE STUDY WAS ALSO UNREMARKABLE. NO PERFORATION OR LEAK WAS IDENTIFIED. THE PHYSICIAN BROUGHT THE PATIENT BACK FOR A DIAGNOSTIC EXPLORATORY LAPAROSCOPY. THE PHYSICIAN IDENTIFIED ONE FASTENER THAT MAY HAVE BEEN TOO TIGHT. THE PHYSICIAN WAS WORRIED ABOUT POSSIBLE GI BLEEDING/LEAK AND DECIDED TO REMOVE THE TARGETED FASTENER AND COMPLETE ANOTHER FUNDOPLICATION FOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Abdominal Pain; Discomfort

  MAUDE report 21129207 ↗
• InjuryJan 10, 2025Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  THE ACCOUNT ALLEGES THAT POST-TIF PROCEDURE, THE PATIENT HAD A SIGNIFICANT SNEEZING SPELL THAT CAUSED MULTIPLE FASTENERS TO DETACH RESULTING IN A GI PERFORATION/LEAK WITHIN THE PATIENT. THE SURGEON COMPLETED AN OMENTAL WRAP TO ADDRESS THIS ISSUE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Fluid Discharge; Perforation of Esophagus

  MAUDE report 21129205 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS DURING A HIATAL HERNIA [HH] REPAIR FOLLOWED BY A TRANSORAL INTRAGASTRIC FUNDOPLICATION [TIF]. DURING THE HHR PROCEDURE, THE PHYSICIAN DILATED THE PATIENT USING AN OVER-THE-WIRE DILATOR [60F] DEVICE, AND WHILE NO OBVIOUS RESISTANCE WAS NOTED, UPON INSPECTION BY THE ENDOSCOPE, THERE WAS TEARING NOTED IN THE ESOPHAGUS CAUSED BY THE INFLATION BALLOON. IT WAS NOT DEEMED TO BE SIGNIFICANT ENOUGH TO ABORT THE TIF PROCEDURE HOWEVER THE TEARING WAS OBSERVED THROUGHOUT A SIGNIFICANT PORTION OF THE LOWER ESOPHAGUS. THE TIF PROCEDURE WAS COMPLETED WITH 4 FIRINGS IN THE POSTERIOR ASPECT, 3 FIRINGS IN THE ANTERIOR, AND 3 FIRINGS IN THE GREATER CURVE AREA TO COMPLETE A 285° FUNDIPLICATION. NO PROBLEMS/ISSUES WERE NOTED DURING THE TIF PROCEDURE. POST-TIF PROCEDURE THE PHYSICIAN ORDERED AN EGD. THE PHYSICIAN NOTED A SUSPICIOUS AREA TOWARD THE POSTERIOR ASPECT OF THE REPAIRED VALVE. LOOKING AT THE INSIDE VIEW OF THE GEJ, THE SUSPICIOUS AREA COULD BE A PERFORATION. THE PHYSICIAN CONFIRMED THE PERFORATION AND PLACED A CLIP IN THE SUSPECTED AREA ALONG WITH FOUR ADDITIONAL CLIPS THAT WERE PLACED TO ADDRESS THE PERFORATION/TEARING OF THE GEJ. THE PATIENT WAS STENTED AND IS DOING WELL

  Patient problems: Perforation of Esophagus; Rupture

  MAUDE report 20616268 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A HHR AND A TIF PROCEDURE WERE BOTH PERFORMED ON A FEMALE PATIENT (B)(6) 2024. THE PATIENT PRESENTED IN THE ED ON (B)(6) 2024 WITH BACK PAIN AND A LARGE PLEURAL EFFUSION, WHICH LOOKED TO BE AN EMPYEMA / INFECTION. THE PATIENT COMPLAINED OF BACK PAIN A FEW DAYS EARLIER DURING A FOLLOW-UP APPOINTMENT, BUT THE PHYSICIAN BELIEVED THAT THE BACK PAIN WAS UNRELATED TO THE TIF PROCEDURE. LAB WORK COMPLETED IN THE ED REVEALED HYPONATREMIA AND A CT PROCEDURE WAS PERFORMED CONFIRMING THAT THE PATIENT DID NOT HAVE AN ESOPHAGEAL PERFORATION. A THORACENTESIS WAS SUCCESSFULLY PERFORMED FOR THE EFFUSION. THE PHYSICIAN HAD A FOLLOW-UP APPOINTMENT WITH THE PATIENT ON (B)(6) 2024, THE PHYSICIAN STATED THAT THE FEMALE PATIENT LOOKED "GOOD." THE PATIENT IS STILL IN THE HOSPITAL RECOVERING FROM THE PLEURAL EFFUSION AND IS WAITING FOR A FOLLOW-UP VISIT FROM THE PHYSICIAN.

  Patient problems: Bacterial Infection; Hyponatremia; Pain; Pleural Effusion; Pleural Empyema

  MAUDE report 20614863 ↗
• InjuryOct 9, 2024Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  THE ACCOUNT ALLEGES THAT TWO DAYS AFTER A CTIF PROCEDURE THE PATIENT RETURNED TO THE HOSPITAL WITH SHORTNESS OF BREATH. A PNEUMOTHORAX WAS DIAGNOSED AND A CHEST TUBE WAS PLACED, NO LEAK FROM THE NEWLY CREATED VALVE WAS DIAGNOSED. PATIENT WAS DISCHARGED BUT STILL HAVING SOME MINOR BREATHING ISSUES. UPON DISCUSSING DETAILS OF THE PATIENT, THE PHYSICIAN DID NOT SUSPECT THERE WAS ANYTHING SPECIFIC RELATED TO THE TIF THAT MAY HAVE CAUSED THE PNEUMOTHORAX. A CT SCAN WAS COMPLETED AFTERNOON OF 10/4/24 - WITH THE NEW IMAGING HE WAS MORE SUSPICIOUS THERE COULD BE SOME KIND PERFORATION IN THE ESOPHAGUS LEADING TO THE PLEURAL EFFUSION. NO UPDATE ON THE STATUS OF THE PATIENT, BUT THEY ARE CURRENTLY AT HOME.

  Patient problems: Discomfort; Dyspnea; Pain; Perforation of Esophagus; Pleural Effusion; Pneumothorax

  MAUDE report 20407375 ↗
• InjurySep 26, 2024Mechanical Problem; Material Protrusion/Extrusion; Patient Device Interaction Problem; Mechanical Problem; Material Protrusion/Extrusion; Patient Device Interaction Problem

  THE ACCOUNT ALLEGES THAT A PATIENT RETURNED WITH A STRICTURE APPROXIMATELY 30 DAYS POST-CTIF PROCEDURE. THE PRIMARY CTIF PROCEDURE OCCURRED ON (B)(6) 2024. THE PATIENT RETURNED TO THE HOSPITAL (B)(6) 2024 AND WAS EXPERIENCING DYSPHAGIA, VOMITING, AND NAUSEA AT THE TIME. AN X-RAY DEMONSTRATED SOME MILD NARROWING OF THE GE JUNCTION. AN EGD WAS PERFORMED ON (B)(6) 2024 AND DEMONSTRATED SEVERE STENOSIS 4CM IN LENGTH. THE PHYSICIAN STATES THAT HE WAS UNABLE TO PASS A SCOPE INTO THE PATIENT'S STOMACH DURING THE EGD PROCEDURE UNTIL AFTER A 15MM BALLOON DILATION ATTEMPT. THE PATIENT HAS BEEN DILATED WITH BOUGIE 3 TIMES SINCE THE ORIGINAL CTIF PROCEDURE. THE PHYSICIAN IDENTIFIED SEVERAL LONG TIF FASTENERS EXTRUDING OUT INTO THE ESOPHAGEAL JUNCTION JUST ABOVE THE EGJ. THE PROTRUDING FASTENERS WERE LIKELY THE CAUSE OF THE ESOPHAGEAL STRICTURE IDENTIFIED WITHIN THIS PATIENT. THE PHYSICIAN USED ENDOSCOPIC SCISSORS TO CUT 4 FASTENERS THAT WERE PROTRUDING INTO THE LUMEN OF THE ESOPHAGUS AND STATED THAT IT LOOKED LIKE THE ESOPHAGUS HAD RELAXED UP A BIT. THE PHYSICIAN INJECTED BOTOX. PLANS TO INSERT PEG TUBE IN 2 WEEKS FOR NUTRITION IF ALL INTERVENTIONS FAIL. THE PHYSICIAN STATES THAT ALL INTERVENT

  Patient problems: Dysphagia/ Odynophagia; Inflammation; Nausea; Pain; Stenosis of the esophagus; Swelling/ Edema; Vomiting; Weight Changes

  MAUDE report 20309767 ↗
• InjurySep 11, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT UNDERWENT A CONCOMITANT HIATAL HERNIA/ENDOSCOPIC FUNDOPLICATION [CTIF] PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED BACK TO THE HOSPITAL 5 DAYS POST-PROCEDURE WITH ABDOMINAL PAIN AND FEVER AND WAS TREATED FOR AN "ABSCESS" THE ACCOUNT STATES THAT THE ABSCESS WAS SUCCESSFULLY DRAINED. THE PATIENT WAS ADMITTED FOR OBSERVATION AND WAS DISCHARGED WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WAS A CONCERN FROM THE SURGEON WHO TREATED THE ABSCESS THAT A SEROSAFUSE FASTENER MAY HAVE GOTTEN "CAUGHT UP" WITH THE MESH USED TO REPAIR THE HIATAL HERNIA CAUSING THE ABSCESS. THE ACTUAL DEVICE WAS DISCARDED AT THE ACCOUNT AND WILL NOT BE RETURNED FOR MERIT MEDICAL EVALUATION.

  Patient problems: Abscess; Fever; Pain

  MAUDE report 20197229 ↗