VENTRALIGHT 5955450Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00801741031717), received between Jul 11, 2017 and May 29, 2026 — classified as 86 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Defective Device” (65 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 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, "A MIDLINE INCISION WAS MADE IN THE EPIGASTRIC REGION. ALL HERNIA SACS WERE TAKEN DOWN SHARPLY. ONE VENTRALIGHT ST W/ ECHO MESH (DEVICE 1) WAS PLACED INTO THE EPIGASTRIC REGION. 2ND PIECE OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 2) WAS PLACED IN THE SUPRAPUBIC MIDLINE REGION AND SECURED IT WITH SUTURES." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE PERITONEAL CAVITY. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED MESH (DEVICE 1 AND DEVICE 2) HAD BUNCHED UP BEYOND THE LEVEL OF THE FASCIA. BOTH (DEVICE 1 AND 2) HAD ALMOST STRETCHED OR BECOME MISPOSITIONED TO BE CONVEX FROM THE ABDOMINAL WALL FASCIA. BOTH VENTRALIGHT ST W/ ECHO MESH (DEVICE 1 AND DEVICE 2) WAS TOTALLY EXCISED."

  Patient problems: Hernia; Pain

  MAUDE report 25334080 ↗
• InjuryMay 28, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1). PER OP NOTES, ¿FASCIAL DEFECT IN THE EPIGASTRIC AREA WAS NOTED. A VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED BENEATH THE FASCIAL DEFECT AND SECURED CIRCUMFERENTIALLY USING TACKS.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA, ISCHEMIC SMALL BOWEL THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, ¿A VERY TIGHT NECKED RECURRENT INCISIONAL HERNIA WITH STRANGULATED, NECROTIC SMALL BOWEL WITHIN ITS CONTENTS. THE HERNIA SAC LOCATED BELOW THE UMBILICUS. THE SMALL BOWEL WAS ISCHEMIC WAS DIVIDED. A PERFIX PLUG (DEVICE 2) WAS NOT USED AT THIS TIME DUE TO THE CONTAMINATION AND THE FACT THAT PATIENT WAS TACHYCARDIC AT THE BEGINNING OF SURGERY.¿ (NOTE: PER MEDICAL RECORD, OPERATIVE NOTE CLEARLY STATES THAT THE MESH WAS NOT IMPLANTED IN THIS PROCEDURE).

  Patient problems: Hernia; Necrosis; Strangulation

  MAUDE report 25312117 ↗
• InjuryMay 20, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED, ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA OF THE ABDOMEN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE IN THE PREVIOUS SCAR IN THE LOWER PART OF THE ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A COMPOSIX KUGEL PATCH (DEVICE 1) WAS PLACED INTO THE PERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT ABDOMINAL PAIN, INFLAMMATION, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIALLY EXPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1) AND LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿A TRANSVERSE INFRAUMBILICAL INCISION WAS MADE THROUGH THE SKIN AND SUBCUTANEOUS TISSUE. PREVIOUSLY PLACED MESH (DEVICE 1) WAS ADHERED, WHICH WAS EXCISED PARTIALLY. LYSIS OF ADHESION WAS PERFORMED. ALL INFLAMMATIONS WERE REMOVED FROM ABDOMEN. THE HERNIA DEFECT WAS CLOSED WITH SUTURES PRIMARILY.¿ ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 25227742 ↗
• InjuryApr 10, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, "A SMALL SKIN INCISION WAS MADE IN THE LEFT UPPER QUADRANT INTO THE ABDOMINAL CAVITY. THERE WERE DENSE ADHESIONS, WHICH WERE TAKEN DOWN. THERE WAS GORE-TEX MESH PLACED IN THE MID ABDOMEN IN THE REGION OF THE UMBILICUS. THE MESH WAS WRINKLED AND HARDENED IN NATURE. THE ABOVE THE MESH, THERE WAS A DEFECT. THE OLD UNKNOWN GORE-TEX MESH WAS DISSECTED OUT. TWO VENTRALIGHT ST W/ ECHO MESH (DEVICE 1 AND 2) WAS PLACED TOGETHER FOR BETTER COVERAGE AND SECURED IT WITH SUTURES." ATTORNEY ALLEGES THAT PATIENT HAD HERNIA RECURRENCE, INFECTION, MESH MIGRATION, MESH SHRINKAGE, ABDOMINAL PAIN.

  Patient problems: Abdominal Pain; Hernia; Unspecified Infection

  MAUDE report 24843041 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RIGHT SPIGELIAN HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS DISSECTED AWAY FROM THE SURROUNDING TISSUE AND EXCISED FROM EDGES OF FASCIA. A BARD FLAT MESH (DEVICE 2) WAS CUT TO SIZE AND PLACED OVER THE CLOSED DEFECT IN ONLAY FASHION AND SECURED IN PLACE USING SUTURES.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿A WIDE MOUTHED DEFECT IN SOFT TISSUE WAS APPRECIATED. A SHEET OF VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED INTO DEFECT AND TACKED ALONG THE CENTRAL PORTION OF DEFECT.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿PATIENT HAD INCISIONAL HERNIA FROM PRIOR TROCAR SITE. THE HERNIA SAC WAS SEPARATED FROM ATTACHMENTS. A LARGE VENTRALEX ST MESH (DEVICE 3) WAS POSITIONED INTO ABDOMINAL CAVITY AND TAILS ANCHORED TO THE OVERLYING FASCIA USING SUTURES.¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH VE

  Patient problems: Abscess

  MAUDE report 24377318 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2025, THE VENTRALIGHT ST W/ ECHO PS WAS REMOVED FROM THE PACKAGING FOR USE AND IT WAS DISCOVERED THAT THE INFLATION TUBE WAS DETACHED FROM THE ECHO PS AND WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED USING NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115277 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE DEFECT WAS CIRCULAR IN ORIENTATION JUST NEAR THE UMBILICUS. THE SEPRAMESH IP (DEVICE #1) WAS PLACED AND TACKED.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST WITH ECHO (DEVICE #2) AND VENTRALIGHT ST WITH ECHO (DEVICE #3). PER OPERATIVE NOTES, ¿THERE WERE EXTENSIVE SMALL BOWEL AND OMENTAL ADHESIONS TO THE PREVIOUS MESH NEAR THE UMBILICUS. THERE WERE TWO ADDITIONAL SMALLER HERNIAS, ONE JUST CEPHALAD TO THE MAIN HERNIA, AND ONE IN THE EPIGASTRIUM. THESE ARE BOTH INCISIONAL HERNIAS. THE LYSIS OF ADHESIONS FROM THE SMALL BOWEL TO THE LOWER LARGER HERNIA MESH WAS EXTREMELY DIFFICULT WITH THE MESH (DEVICE #1) HAVING BEEN FUSED TO THE SMALL BOWEL EXTENSIVELY, UP INTO THE HERNIA SAC. ADHESIONS WERE LYSED AND SMALL BOWEL RESECTION WAS PERFORMED. THE HERNIA WAS REPAIRED USING VENTRALIGHT ST WITH ECHO (DEVICE #2) AND VENTRALIGHT ST WITH ECHO (DEVICE #3). ONE MESH WAS PLACED ABO

  Patient problems: Adhesion(s); Hernia; Wound Dehiscence

  MAUDE report 23730322 ↗
• 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 VENTRALIGHT ST W/ ECHO PS FROM LOT NUMBER HUKN1945 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632359 ↗
• InjuryMay 6, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AT RIGHT UPPER QUADRANT THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA WAS IDENTIFIED LATERAL TO RECTUS. THE FASCIA WAS CLOSED AND A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2021 - PATIENT WAS INCISIONAL HERNIA WITHOUT OBSTRUCTION AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2). PER OPERATIVE NOTES, "A PALPABLE REGION OF FASCIAL WEAKNESS IN RIGHT UPPER QUADRANT WAS NOTED. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2) WAS PLACED AND TACKED." (NOTE: THERE WAS NO MENTION/VISUALIZATION OF THE PREVIOUSLY PLACED BARD FLAT MESH (DEVICE #1) DURING THIS PROCEDURE) (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA AT RIGHT UPPER QUADRANT AND SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX ST MESH (DEVICE #3). PER OPERATIVE NOTES, "THE EDGE OF A PREVIOUS MESH (DEVICE #2) REPAIR WAS SEEN. THE HERNIA WAS JUST INFERIOR EDGE OF THIS. A PHASIX ST MESH (DEVICE #3) WAS SUTURED."

  Patient problems: Hernia; Scar Tissue

  MAUDE report 21965577 ↗
• InjuryNov 29, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ENTIRE HERNIA SAC WAS OPENED UP AND SMALL BOWEL WAS STUCK INTO SAC, LOOKS LIKE ISCHEMIC AND DUSKY WAS FREED UP FROM SAC. THE SAC WAS FREED UP ALL AROUND THE EDGE AND PLACED A PIECE OF SEPRAFILM UNDERNEATH AND THEN PLACED THE COMPOSIX KUGEL MESH (DEVICE #1) WAS SEWN CIRCUMFERENTIALLY WITH INTERRUPTED SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #2) AND REMOVAL OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND CLEARED FROM SUBCUTANEOUS ATTACHMENTS. PARTIALLY REDUCIBLE INCARCERATED SMALL BOWEL WAS NOTED IN HERNIA SAC AND OBSTRUCTION AND ADHESION CAUSING MESH WAS NOTED. THE OLD COMPOSIX KUGEL MESH (DEVICE #1) WAS REMOVED FROM THE FASCIAL ATTACHMENTS. THE SMALL BOWEL WAS DENSELY ADHERED TO MESH (DEVICE #1) WAS RESECTED. ADDITIONAL VENTRAL HERNIA SAC IN THE SUBCUTANEOUS AREA WAS IDENTIFIED AND REMOVED. THE COMP

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

  MAUDE report 20810186 ↗
• MalfunctionNov 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE SURGEON INSERTED VENTRALIGHT ST W/ ECHO PS INTO 8MM TROCAR, AND THE MESH RIPPED. IT WAS REPORTED THAT THE MESH WAS REMOVED AND ANOTHER VENTRALIGHT ST MESH W/ ECHO PS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728922 ↗
• MalfunctionOct 29, 2024

  PART OF THE INFLATOR SYSTEM (YELLOW HUB) CAME OFF MESH & INTO PATIENT. REMOVED FROM PATIENT. NO PROBLEM COMPLETING CASE. MANUFACTURER RESPONSE FOR MESH, SURGICAL, POLYMERIC, VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM (PER SITE REPORTER). MANUFACTURER ISSUED RGA#.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557154 ↗
• InjuryOct 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS PER MEDSUN VOLUNTARY REPORT #(B)(4). "EXTRA-GYNECOLOGICAL SURGICAL MESH COMPOSITE POLYMER PATIENT HAD LAPAROSCOPIC HERNIA REPAIR SURGERY ON (B)(6) 2024. TODAY DR. (B)(6) STATED HE COULD NOT REMEMBER REMOVING POSITIONING BALLOON FROM MESH. PATIENT SCHEDULED FOR DIAGNOSTIC LAPAROSCOPY TO VERIFY IF BALLOON WAS RETAINED. LAPAROSCOPY PERFORMED; BALLOON IDENTIFIED STILL ATTACHED TO MESH ON ABDOMINAL WALL. BALLOON RETRIEVED AND SENT TO LAB FOR GROSS ID. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MESH IMPLANTED. WHAT PROBLEM DID THE USER HAVE: NOT KNOWN. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN;"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404588 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE, THE YELLOW ANCHOR ON THE INFLATION TUBE OF VENTRALIGHT ST MESH W/ ECHO PS CAME LOOSE AND SLID DOWN THE INFLATION TUBING WHICH MADE THE MESH IMPOSSIBLE TO LAY FLAT. IT WAS REPORTED THAT THE SURGEON TRIED TO CUT THE YELLOW ANCHOR OFF, BUT IT WAS TOO HARD, SO HE SUTURED HALF OF THE MESH IN PLACE AND THEN REMOVED THE ECHO PS AND YELLOW ANCHOR. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED BY USING THE SAME MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076062 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE, AFTER CLOSING THE DEFECT, THE SURGEON ATTEMPTED TO PULL THE INFLATION TUBE UP THROUGH THE ABDOMEN AND THE YELLOW ANCHOR OF THE VENTRALIGHT ST W/ECHO PS INFLATION TUBING CAME OFF. THE ANCHOR WAS REMOVED FROM PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH A VENTRALIGHT ST MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031155 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A VENTRALIGHT ST W/ ECHO PS WAS USED DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024. IT WAS REPORTED THAT THE YELLOW ANCHOR OF VENTRALIGHT ST W/ ECHO PS DETACHED AND FELL INTO THE PATIENT. IT WAS ALSO REPORTED THAT YELLOW ANCHOR WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937844 ↗
• InjuryMay 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A PROCEDURE, THE PATIENT WAS IMPLANTED WITH VENTRALIGHT ST MESH USING ECHO PS ON (B)(6) 2024. IT WAS REPORTED THAT THE "HERNIA PATCH THAT HAS BEEN PAINFUL AND HAS TO BE REMOVED. PATIENT IS WAITING FOR AN MRI."

  Patient problems: Pain

  MAUDE report 19330860 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, THE YELLOW ANCHOR OF THE VENTRALIGHT ST ECHO PS BECAME TRAPPED UNDER THE PATIENT¿S UMBILICUS WHEN THE SURGEON PULLED THE BLUE RETRIEVAL LOOP OUT OF PATIENT THROUGH THE UMBILICUS. IT WAS REPORTED THAT NO ANATOMICAL DIFFICULTLY (SCAR TISSUE OR EXCESSIVE OMENTUM) WAS NOTED. THE SURGEON REMOVED THE ECHO PS AND IMPLANTED THE MESH WITHOUT THE USE OF THE ECHO PS. THE MESH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958281 ↗
• InjuryDec 14, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST AND VENTRALIGHT ST ON (B)(6) 2020 AND/OR (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH 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: Adhesion(s); Hernia; Insufficient Information; Unspecified Infection

  MAUDE report 18323936 ↗
• InjuryOct 21, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST WITH ECHO (5955459) ON (B)(6) 2019 AND VENTRALIGHT ST WITH ECHO (5955680) ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST WITH ECHO (5955459). 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 17982015 ↗
• InjurySep 30, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX AND VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. ATTORNEY ALSO ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2017 AND (B)(6) 2018. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 17849178 ↗
• MalfunctionJun 15, 2023Break; Break

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE A VENTRALIGHT ST MESH W/ ECHO PS WAS ATTEMPTED TO BE USED. WHEN THE INFLATION TUBE WAS PULLED THROUGH THE SKIN INCISION AFTER DEPLOYING THE MESH INTO THE ABDOMINAL CAVITY, THE INFLATION TUBE BROKE. THE SURGEON DID NOT USE THE MESH AND IT WAS REMOVED. AS REPORTED, A NEW MESH WAS PROVIDED TO COMPLETE THE CASE WITH NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133509 ↗
• MalfunctionMay 19, 2023Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023, THE VENTRALIGHT ST MESH W/ECHO POSITIONING SYSTEM WAS USED. IT WAS REPORTED THAT THE VENTRALIGHT ST TUBING FRACTURED WHILE PULLING OUT FROM THE UMBILICUS. ADDITIONAL SURGICAL TIME WAS NEEDED TO SECURE THE MESH. AS REPORTED, THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965745 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE IT WAS NOTED THAT THE VENTRALIGHT ST W/ECHO PS COIL WAS PULLED OUT WHEN REMOVED FROM THE PACKAGE PRIOR TO USE. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGE. THE PROCEDURE WAS COMPLETED USING NEW MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818142 ↗
• MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE THE VENTRALIGHT ST W/ECHO PS WAS REMOVED FROM THE PACKAGING AND PLACED ONTO THE STERILE FIELD, IT WAS NOTICED THAT THE INFLATION TUBING WITH THE YELLOW ANCHOR WAS NOT ATTACHED TO THE ECHO PS. IT WAS REPORTED THAT THE DEVICE WAS NOT USED AND NEW VENTRALIGHT ST W/ ECHO PS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582215 ↗