Phasix 1200710Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741095337), received between Oct 1, 2019 and Sep 22, 2026 — classified as 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Patient-Device Incompatibility

  Patient problems: Urticaria

  MAUDE report 50860229 ↗
• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2018- Patient was diagnosed with left incarcerated inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 1). Per op notes, "In right inguinal region, no hernia was noted. In left inguinal region, hernia was identified and dissected. A 3DMax Mesh (Device 1) was placed covering the hernia defect into the preperitoneal space and was sutured." (b)(6) 2019- Patient was diagnosed with incisional hernia, thereby underwent open repair with implant of Ventrio ST Mesh (Device 2). Per op notes, "Through upper midline epigastric incision, hernia defect was identified and was dissected. An extra-large Ventrio ST Mesh (Device 2) was inserted into preperitoneal space and sutured."(b)(6) 2019- Patient was diagnosed with infected mesh, incisional hernia, thereby underwent open repair with explant of Ventrio ST Mesh (Device 2), implant of Phasix ST Mesh (Device 3). Per op notes, "Hernia developed seroma and penetrated the Ventrio ST Mesh (Device 2) and this mesh was excised. A Phasix ST Mesh (Device 3) was placed in the preperitoneal space and was sutured."(b)(6) 2019- Patient was diagnosed with recurrent incisional hernia, thereby u

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 50091023 ↗
• InjuryFeb 15, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "VALIDATION OF THE ACS-NSQIP SURGICAL RISK CALCULATOR FOR PATIENTS WITH PARAOESOPHAGEAL HERNIAS UNDERGOING ROBOTIC REPAIR" THE OBJECTIVE OF THIS STUDY WAS TO MEASURE THE ACCURACY OF THIS CALCULATOR ON PARAOESOPHAGEAL HERNIA (PEH) REPAIR. PROCEDURES PERFORMED BETWEEN 2019 AND 2023 WERE RETROSPECTIVELY COLLECTED REGARDING DEMOGRAPHICS, OPERATIVE VARIABLES, AND OUTCOMES WITH A 30-DAY FOLLOW-UP. THIRTEEN OUTCOMES MEASURED BY NSQIP-ACS CALCULATOR WERE MEASURED. OBSERVED AND PREDICTED RATES WERE COMPARED BY RECEIVER OPERATING CURVES (ROC) AND LENGTH OF STAY WAS COMPARED BY WILCOXON SIGNED RANK TEST. A TOTAL OF 203 PARAOESOPHAGEAL HERNIA REPAIRS ON PATIENTS WITH A MEDIAN AGE OF 68 (IQR 61-75) AND 70.9% (N = 144) PREDOMINANTLY FEMALE. THE SIZE OF THE PARAOESOPHAGEAL HERNIA (PEH) WAS LARGE OR GIANT IN 59.1% (N = 120) AND MESH WAS PLACED IN 70.4% (N = 143). THE PREDICTED RISK WAS CONSISTENTLY HIGHER THAN OBSERVED EVENTS ON ALL BUT DISCHARGE DESTINATIONS. EIGHT OUTCOMES HAD NO EVENT TO MEASURE; HOWEVER, THE CALCULATOR ACCURATELY PREDICTED A RISK OF LESS THAN OR EQUAL TO 1% ON ALL OF THESE. THE AREA UNDER THE CURVE (AUC) WAS FAIR (0.6¿0.79) ON DISCHARGE TO NURSING OR REHAB

  Patient problems: Hernia

  MAUDE report 24341768 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED, BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST MESH FROM LOT NUMBER HUKQ1640 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630104 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR, THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED, BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST MESH FROM LOT NUMBER HUKQ1513 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630103 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON 05-NOV-2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS 4 PHASIX ST MESH FROM LOT NUMBER HUKS0026 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630102 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED, BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS 4 PHASIX ST MESH FROM LOT NUMBER HUKT1991 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630101 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, ON 05-NOV-2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED, BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST MESH FROM LOT NUMBER HUKS0040 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630100 ↗
• InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED THE PATIENT UNDERWENT A PARAESOPHAGEAL HERNIA REPAIR ON (B)(6) 2025 WITH THE IMPLANT OF A PHASIX ST MESH. POST IMPLANT THE PATIENT IS EXPERIENCING FULL BODY HIVES. PATIENT IS CURRENTLY UNDERGOING A DERMATOLOGY AND ALLERGY WORK UP.

  Patient problems: Urticaria

  MAUDE report 21547846 ↗
• MalfunctionJan 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED ON (B)(6) 2024, WHEN THE PHASIX ST MESH WAS OPENED FOR A ROBOTIC INGUINAL HERNIA REPAIR CASE A HOLE WAS NOTED IN THE MESH MATERIAL. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING. THE MESH WAS NOT USED IN THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178164 ↗
• MalfunctionMay 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A HIATAL HERNIA REPAIR PROCEDURE, WHILE OPENING THE PHASIX ST MESH A FOREIGN MATERIAL (HAIR) WAS FOUND IN THE INNER STERILE PACKAGE. IT WAS REPORTED THAT A NEW PHASIX ST MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371404 ↗
• InjuryApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2024 WITH THE IMPLANT OF A PHASIX ST MESH. REPORTEDLY, THE MESH WAS PLACED WITH 3 MM OF SPACE BETWEEN THE ESOPHAGUS AND MESH. AS REPORTED 4 WEEKS POST IMPLANT, THE MESH ERODED INTO THE ESOPHAGUS RESULTING IN THE NEED FOR AN ESOPHAGECTOMY. AS REPORTED, THE PATIENT HAD BEEN COMPROMISED, WITH AN UNKNOWN CAUSE OR CONDITION, PRIOR TO THE IMPLANT PROCEDURE AND WAS INTUBATED.

  Patient problems: Erosion

  MAUDE report 19215595 ↗
• InjuryFeb 20, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL PHASIX ST MESH 7CM X 10CM ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX ST MESH 7CM X 10CM. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 18736596 ↗
• MalfunctionOct 26, 2023Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method; Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method

  AS PER MEDWATCH FORM, "INCOMPATIBLE MESH WAS PLACED IN PATIENT. PATIENT WAS BROUGHT BACK TO SURGERY HOURS LATER TO REPLACE WITH A MESH THAT COULD BE PLACED ADJACENT TO THE BOWEL. THERE WERE NO COMPLICATIONS REPLACING THE MESH. IT WAS DISCOVERED THE INITIAL MESH PLACED COULD NOT BE PLACED NEXT TO THE BOWEL. DURING OUR EVENT REVIEW WE DISCOVERED THAT THE MESH PRODUCTS HAVE NEARLY THE SAME NAME AND PACKAGING. PHASIX AND PHASIX ST. THERE IS NO DESCRIPTION ON THE MESH PACKAGE LABEL THAT INDICATES IF ONE OR THE OTHER PRODUCT CAN OR CANNOT BE PLACED NEXT TO THE BOWEL. BOTH PRODUCTS ARE BIOLOGICS. THE PRODUCT REP KNEW WHICH MESH COULD BE PLACED BY THE BOWEL. HOWEVER WE COULD NOT QUICKLY REACH THE PRODUCT REP THROUGH THE COMPANY WEBSITE PHONE NUMBERS. IT TOOK SEVERAL PHONE CALLS AND TRANSFERS. SECOND, THE INSTRUCTIONS INSIDE THE PACKAGE DO INDICATE WHETHER OR NOT THE MESH CAN BE PLACED NEXT TO THE BOWEL. HOWEVER, THIS INSTRUCTION IS INSIDE A PRODUCT THAT IS MANY THOUSANDS OF DOLLARS AND THE TEAM DIDN'T WANT TO WASTE AN EXPENSIVE PRODUCT BY OPENING IT. WE LATER DISCOVERED THE OUTER PACKAGE CAN BE OPENED FOR THE INSTRUCTIONS WITHOUT COMPROMISING THE INTEGRITY OF THE MESH PRODUCT. OUR REQUEST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014090 ↗
• MalfunctionMay 11, 2023Material Separation; Material Separation

  AS REPORTED A PHASIX ST MESH WAS CUT FOR A PROCEDURE, WAS ENTERED INTO A COMPLETELY DRY CAVITY, ONCE IN THE CAVITY IT CAME INTO CONTACT WITH BLOOD AND WAS MOISTENED WITH THE SAME BLOOD FROM THE PATIENT AND THE SALINE SOLUTION THAT WAS IN THE CAVITY FROM A PREVIOUS WASH WERE THE ONLY TWO SOLUTIONS THAT WERE IN THE CAVITY. ONCE THE MESH WAS MOISTENED IT COMPLETELY FOLDED AND FIXATION WAS IMPOSSIBLE. THE MESH WAS REMOVED AS THE HYDROGEL CAME OFF AND THE MESH BECAME BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911589 ↗
• MalfunctionMay 3, 2023Material Separation; Material Separation

  AS REPORTED, A PHASIX ST MESH WAS PLACED INTO THE PATIENT¿S BODY WITHOUT HYDRATION. IT WAS REPORTED THAT UPON CONTACT WITH THE TISSUE, THE MESH BENDS COMPLETELY AND FIXATION BECOMES IMPOSSIBLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861806 ↗
• InjuryApr 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A ROBOTIC RECURRENT PARAESOPHAGEAL HERNIA REPAIR SURGERY ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH PHASIX ST MESH. AS REPORTED, THE MESH WAS IMPLANTED AT THE HIATUS IN A REVERSE C CONFIGURATION, SECURED WITH INTERRUPTED STITCHES. ON (B)(6) 2023, ENDOSCOPIC PROCEDURE WAS PERFORMED TO PLACE A PIGTAIL CATHETER THROUGH THE ERODED MESH AREA AND FISTULOUS CONNECTION TO ABSCESS. IT WAS REPORTED THAT THE MESH WAS CLEARLY VISIBLE HAVING ERODED INTO CARDIA OF STOMACH 21 MONTHS AFTER INITIAL SURGERY. DOCTOR REPORTS ¿NO PATIENT CONDITION THAT PREDISPOSED TO EROSION.¿

  Patient problems: Abscess; Erosion; Fistula

  MAUDE report 16781377 ↗
• InjuryDec 1, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH AND PHASIX ON 21-JUN-2019 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 15895050 ↗
• InjurySep 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX ST MESH FOR A VENTRAL HERNIA REPAIR ON (B)(6) 2022. AS REPORTED, ABOUT 2 MONTHS POST-IMPLANT, THE MESH WAS NOTED TO BE PROTRUDING FROM THE ABDOMEN. AS REPORTED, THE SURGEON "DID NOT FEEL THERE IS ANYTHING WRONG WITH THE PHASIX ST MESH, JUST THE PATIENT'S FASCIA". AS REPORTED, THE SURGEON DECIDED TO DEBRIDE THE WOUND AND WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15340057 ↗
• MalfunctionMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2019 - SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROSCOPIC PARAOESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE USING A BARD/DAVOL PHASIX ST WHICH WAS FIXATED USING NON-BARD/DAVOL SUTURES. FULL SKIN CLOSURE FOR ACHIEVED USING STAPLES AND ADHESIVE SKIN CLOSURE. (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH ABDOMINAL DISTENTION. NO ACTION TAKEN. (B)(6) 2019 - SUBJECT PATIENT WAS DISCHARGED TO HOME. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Abdominal Distention

  MAUDE report 14468976 ↗
• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF FIRST TIME RECURRENT PARAESOPHAGEAL HIATAL HERNIA ALONG WITH TOUPET FUNDOPLICATION AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURES. A PHASIX ST MESH WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY, FIXATED USING VICRYL SUTURES AT 4 FIXATION POINTS. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH PARAESOPHAGEAL HIATAL HERNIA (PEH) RECURRENCE FOLLOWING AN ESOPHAGRAM SCAN. ON (B)(6) 2018 - DURING PHYSICAL EXAM PARAESOPHAGEAL HIATAL HERNIA (PEH) RECURRENCE WAS NOTED. THE AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A NON-SERIOUS ADVERSE EVENT OF MILD SEVERITY, AND HAS NOT RESOLVED, THERE HAS BEEN NO ACTION TAKEN. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Hernia

  MAUDE report 14434650 ↗
• InjuryMay 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT ROBOTICALLY ASSISTED HIATAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2020 WITH THE IMPLANT OF A BARD/DAVOL PHASIX ST MESH. IT WAS REPORTED THAT THE SURGEON MAY HAVE CUT A KEYHOLE IN THE MESH AND WRAPPED IT AROUND THE CRUS, DURING IMPLANT. THE PATIENT UNDERWENT MESH REMOVAL SURGERY ON (B)(6) 2021, WITH TAKEDOWN OF NISSEN DUE TO DYSPHAGIA. MESH WAS NOTED TO BE ERODING INTO POSTERIOR ASPECT OF ESOPHAGUS. ESOPHAGOGASTRODUODENOSCOPY (EGD) DONE DURING THE PROCEDURE SHOWED MESH INSIDE LUMEN OF ESOPHAGUS AND PIECES OF MESH WERE REMOVED ENDOSCOPICALLY. THE ESOPHAGUS WAS REPAIRED. THE PATIENT IS DOING WELL.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 11811344 ↗
• InjuryJul 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC HIATAL HERNIA REPAIR USING A PHASIX ST MESH AND PERMANENT BARBED SUTURES. THE PATIENT WAS HAVING DYSPHAGIA (DIFFICULTY SWALLOWING) 12 MONTHS POST-IMPLANT; AN ENDOSCOPY WAS PERFORMED TO LOOK AT THE ENACTMENT OF THE ESOPHAGUS. THE ENDOSCOPY SHOWED THE MESH FIBERS TO BE INTACT. DURING THE ENDOSCOPY, IT WAS OBSERVED THAT THE PHASIX ST MESH AS WELL AS THE PERMANENT BARBED SUTURES USED TO CLOSE THE CRURA HAD ENTERED THE ESOPHAGUS. IT IS UNCLEAR THAT THE EROSION IS DUE TO THE SUTURES PENETRATING THE ESOPHAGUS OR THE MESH. ADDENDUM: IT WAS REPORTED THAT AN ELDERLY WOMAN PATIENT UNDERWENT REPAIR OF A LARGE TYPE 3 PEH (PARAESOPHAGEAL HERNIA) WITH REINFORCEMENT OF THE CRURAL CLOSURE WITH A ¿REVERSE C¿ PHASIX ST PATCH ABOUT A YEAR AGO. THE PATIENT DEVELOPED DYSPHAGIA AT SOME POINT AND WAS EVALUATED WITH A BARIUM SWALLOW THAT WAS "PRETTY MUCH NORMAL." IT WAS REPORTED THAT THE PATIENT UNDERWENT ENDOSCOPY AND REPEAT ENDOSCOPY, WHICH DEMONSTRATED SOME SUTURE MATERIAL AND PHASIX MATERIAL. THE PHASIX MATERIAL WAS STILL PRETTY STRONG AND RESISTED ATTEMPTS TO CUT IT OR PULL IT APART, ALTHOUGH SOME WAS REMOVED. THE PATIENT¿S DYSPHAGIA IMPROVED. THE P

  Patient problems: Dysphagia/ Odynophagia; Erosion; Injury

  MAUDE report 10217545 ↗
• InjuryOct 1, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A ROBOTIC ASSISTED HIATAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A BARD PHASIX ST MESH. IT IS ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE HIATAL HERNIA REPAIR DURING WHICH IT WAS REPORTED THAT THE PHASIX ST MESH WAS ADHERED AND HAD ERODED INTO THE PATIENT'S ESOPHAGUS. AS REPORTED, THE SURGEON DID NOT REMOVE ANY OF THE MESH AND PLACED A G-TUBE AS THE PATIENT CANNOT CONSUME ANY FOOD OR DRINK BY MOUTH. IT IS ALLEGED THAT THE PATIENT WILL EITHER HAVE TO KEEP THE G-TUBE IN PLACE INDEFINITELY OR WILL HAVE TO REMOVE SOME OF THE PATIENT'S ESOPHAGUS.

  Patient problems: Adhesion(s); Erosion

  MAUDE report 9142067 ↗