VENTRALIGHT 5955600Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00801741031731), received between Jul 10, 2017 and Jul 28, 2026 — classified as 57 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Defective Device” (42 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 84 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2009- Patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "Through upper midline incision, hernia sac with incarcerated omentum was identified in the abdominal region which was then reduced. A Ventralex Mesh (Device 1) was placed intraperitoneally and was sutured." On (b)(6) 2011- Patient was diagnosed with chronic pelvis pain, adhesion, thereby underwent robotic assisted laparoscopic repair. Per op notes, "Adhesions from omentum to the anterior abdominal wall was identified. Adhesions were lysed and the omentum was reduced." On (b)(6) 2011- Patient was diagnosed with abdominal pain, adhesion, thereby underwent laparoscopic repair. Per op notes, "Extensive adhesion from the omentum to the previous hernia repair in mid upper abdomen."On (b)(6) 2012- Patient was diagnosed with pelvic pain, adhesion, thereby underwent robotic assisted laparoscopic repair. Per op notes, "Dense adhesions from the omentum to the anterior abdominal wall were identified and the adhesions were lysed."On (b)(6) 2014- Patient was diagnosed with umbilical hernia, thereby underwent exp

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50050074 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "SUPRAUMBILICAL INCISION WAS MADE. THE HERNIA SAC WITH INCARCERATED OMENTUM WAS NOTED AND REDUCED. A VENTRALEX MESH WAS PLACED AND TACKED USING SORBAFIX TACKER." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 2). PER OP NOTES, "EXTENSIVE ADHESIONS TO THE OMENTUM AND ANTERIOR ABDOMINAL WALL WERE TAKEN DOWN. THE PREVIOUS MESH (DEVICE 1) HAD COME LOOSE AND ROLLED UP UNDER AND WAS DENSELY ADHERENT WITH OMENTUM WERE TAKEN DOWN. THE OLD MESH (DEVICE 1) WAS EXCISED AND REMOVED. THE HERNIA DEFECT WAS NOTED AND REDUCED. A VENTRALIGHT ST USING ECHO PS (DEVICE 2) WAS PLACED AND TACKED USING SORBAFIX TACKER." ON (B)(6) 2020 - PATIENT HAD RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH EXCISION OF VENTRALIGHT ST USING ECHO PS (DEVICE 2).

  Patient problems: Hernia

  MAUDE report 25664545 ↗
• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST WITH ECHO PS MESH (DEVICE 1 AND 2). PER OP NOTES, "THE HERNIA DEFECT WAS IDENTIFIED AND CLEARED FROM ALL ADHESIONS. THE DEFECT WAS EXTENDING FROM SLIGHTLY ABOVE THE SYMPHYSIS PUBIS UPWARDS. THE TOP COMPONENT OF THE HERNIA WAS MADE OF A SWISS CHEESE DEFECT. A VENTRALIGHT ST WITH ECHO PS (DEVICE 1) WAS PLACED AND SECURED WITH MULTIPLE TACKS AND INTRACORPORAL STITCHES. THE SECOND MESH VENTRALIGHT ST WITH ECHO PS (DEVICE 2) WAS PLACED TO COVER THE SWISS CHEESE DEFECT ABOVE THE UMBILICUS. THIS OVERLAPPED WITH THE LOWER MESH INFERIORLY AND SECURED WITH TACKS AND SUTURES." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, "A VERTICAL INCISION WAS MADE OVER THE PALPABLE RECURRENCE. THE HERNIA SAC WAS IDENTIFIED. A LOOP OF BOWEL WAS STUCK IN IT WITH SOME ACUTE ADHESIONS THAT WAS SEPARATED. WEAKENED FASCIA UNDERNEATH THE DEFECT WAS OPENED AND SNAKED BETWEEN TWO PIECES OF MESH, BOTH OF WHICH WERE STAYING IN THEIR PLACE BUT THE BOWEL WAS WENT BETWEEN TH

  Patient problems: Abdominal Pain; Adhesion(s); Hernia

  MAUDE report 25648760 ↗
• MalfunctionMay 14, 2026Break

  AS REPORTED, ON (B)(6) 2026 DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE WHILE PULLING THE INFLATION TUBE UP AND OUT THROUGH THE ABDOMINAL WALL ON A VENTRALIGHT ST W/ ECHO PS, THE INFLATION TUBE BROKE. REPORTEDLY, ALL THE MESH AND COMPONENTS WERE REMOVED AND NOT USED. A NEW VENTRALIGHT ST W/ ECHO WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172974 ↗
• MalfunctionMay 11, 2026Separation Failure

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE ON (B)(6) 2026, THE SURGEON WAS UNABLE TO REMOVE THE ECHO PS FROM THE VENTRALIGHT ST W/ ECHO PS MESH. REPORTEDLY, MULTIPLE ATTEMPTS WERE MADE, BUT THE COMPONENTS COULD NOT BE DISENGAGED AS EXPECTED. THE SURGEON REMOVED THE MESH FROM THE PATIENT'S BODY AND USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135904 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 1). PER OP NOTES, "SYNTHETIC MESH WAS REMOVED. PLACED A PHASIX MESH (DEVICE 1) INTO THE ABDOMEN USING TACKS." (PPF/MRR). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 2) AND VENTRALIGHT ST (DEVICE 3). PER OP NOTES, "ADHESIONS WERE TAKEN DOWN. NOTED THE MESH (DEVICE 1) IN THE ABDOMINAL WALL. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE 2) AND A VENTRALIGHT ST (DEVICE 3) WERE PLACED TO COVER THE PREVIOUS MESH (DEVICE 1) INTO THE ABDOMINAL WALL USING PROLENE SUTURES." (PPF/MRR). (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 4) AND LYSIS OF ADHESIONS. PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORMED, SEPARATED THE MESH FROM THE HEALTHY FASCIA. A PHASIX MESH (DEVICE 4) WAS PLACED USING SUTURES." (PPF/MRR).

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23786739 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A LAPAROSCOPIC UMBILICAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE, IT WAS REPORTED THAT THE YELLOW ANCHOR OF THE VENTRALIGHT ST ECHO PS BECAME DETACHED FROM THE INFLATION TUBE. HOWEVER, THE SAME MESH WAS SUCCESSFULLY IMPLANTED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696396 ↗
• InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1). PER OP NOTES, ¿A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1) WAS PLACED IN THE ANTERIOR ABDOMINAL WALL USING TACKERS.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2 & #3). PER OP NOTES, ¿THERE WERE ADHESIONS EXTENDING FROM THE MID TO LOWER ABDOMEN. THERE WAS AN EDGE OF THE OLD MESH (DEVICE #1) THAT HAD CURLED OVER. TWO VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2 & #3) WERE PLACED IN THE ABDOMEN TO COVER THE OLD MESH.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS WITH PERFORATED CECUM THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1, #2 & #3). PER OP NOTES, ¿A MODERATE AMOUNT OF PURULENT FLUID WAS NOTED. PERFORMED ADHESIOLYSIS. IDENTIFIED THE PERFORATION OF THE CECUM AND WAS TAKEN DOWN. THERE WAS A RETAINED FOREIGN BODY, WHICH APPEARED TO BE A PREVIOUSLY PLACED ECHO MESH (DEVICE #1, #2 & #3). THIS WAS NOTED TO BE INTRACORPOREAL I

  Patient problems: Abscess; Adhesion(s); Bowel Perforation

  MAUDE report 22132947 ↗
• InjuryMar 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS FREED FROM THE FASCIA AND THE UMBILICAL SKIN TACK. THEN A VENTRALEX ST MESH (DEVICE #1) WAS PLACED INTRAABDOMINALLY AND ANCHORED IT TO THE EDGE OF THE FASCIA TO THE EDGES OF THE MESH USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SURGICAL WOUND INFECTION THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THERE WAS A PURULENT OLD LOOKING HEMATOMA. THE MESH (DEVICE #1) DID APPEAR TO BE INTACT, AND THE AREA OF INFECTION APPEARED TO BE MINIMAL.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH EXPOSED MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE EDGES OF THE MESH WERE UNDER THE FASCIA, THE REST CAME THROUGH THE HERNIA DEFECT. THERE WERE SOME OMENTAL ADHESIONS FROM THE UNDERSIDE OF THE MESH. THEN THE VENTRALEX ST MESH (DEVICE #1) WAS REMOVED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMP

  Patient problems: Hernia

  MAUDE report 21706234 ↗
• MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH A VENTRALIGHT ST W/ECHO PS USING 12 MM TROCAR AND A CARTER THOMPSON DEVICE. A SMALL (1MM) PIECE OF THE RETRIEVAL LOOP BROKE OFF AND FELL INTO THE PATIENT'S ABDOMEN WHEN PULLING IT UP THROUGH THE ABDOMINAL WALL. AS REPORTED, IT¿S POSSIBLE THE CARTER THOMPSON DEVICE MAY HAVE CLIPPED THE RETRIEVAL LOOP. THE SURGEON WAS NOT ABLE TO LOCATE OR RETRIEVE THE PIECE, AND IT WAS LEFT IN VIVO. THE CASE WAS COMPLETED AND NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21527578 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT UNDERWENT THE REPAIR OF A RECURRENT VENTRAL HERNIA REPAIR USING A VENTRALIGHT ST W/ ECHO PS. THE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH A NON-BARD MESH PLACED IN AN ONLAY POSITION WHICH REMAINED IMPLANTED. WHEN THE SURGEON TOOK THE CARTER THOMPSON TO PULL THE INFLATION TUBE OF THE ECHO PS UP AND THROUGH THE SKIN, THE YELLOW ANCHOR GOT CAUGHT ON THE BOTTOM SIDE OF THE PREVIOUSLY IMPLANTED MESH AND CAME OFF. THE SURGEON DECIDED TO LEAVE THE YELLOW ANCHOR IN THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY, AND NO FURTHER INTERVENTION HAS BEEN PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19457221 ↗
• MalfunctionFeb 27, 2024Break; Break

  AS REPORTED, DURING THE PLACEMENT OF VENTRALIGHT ST MESH USING ECHO PS IN A ROBOTIC INCISIONAL HERNIA REPAIR, WHEN PULLING THE RETRIEVAL LOOP ON THE INFLATION TUBE UP THROUGH THE ABDOMINAL WALL, THE INFLATION TUBE BROKE. THE EXPERIENCED SURGEON WAS ABLE TO RETRIEVE THE REMAINING INFLATION TUBING, COMPLETED INFLATION OF THE ECHO PS BALLOON AND FIXATED THE MESH SUCCESSFULLY. ALL PIECES (ECHO BALLOON, CONNECTORS, AND INFLATION TUBING) WERE ACCOUNTED FOR AND REMOVED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788888 ↗
• InjuryJan 31, 2024Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  AS ALLEGED, DURING A PROCEDURE THE PATIENT WAS IMPLANTED WITH VENTRALIGHT ST W/ ECHO MESH. IT WAS ALLEGED THE MESH RUPTURED POST IMPLANT AND ON (B)(6) 2023 THE PATIENT UNDERWENT A 6-HOUR SURGERY TO REMOVE THE MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: AS REPORTED, PATIENT WAS DIAGNOSED WITH AN INCISIONAL HERNIA AND UNDERWENT REPAIR WITH IMPLANT OF UNKNOWN MESH IN 1995. AS REPORTED IN (B)(6) 2023 PATIENT HAD DEVELOPED WOUND DEHISCENCE, WOUND HEALING ISSUES AND DRAINAGE. ON (B)(6) 2023 DURING UMBILICAL HERNIA REPAIR PATIENT UNDERWENT REMOVAL OF THE PREVIOUS MESH (UNKNOWN) AND IMPLANT OF A VENTRALIGHT ST MESH USING ECHO PS. AS REPORTED, THIS PAST WEEK ((B)(6) 2024) PATIENT STARTED EXPERIENCING A BURNING SENSATION, WOUND DRAINAGE AND DISCOLORATION AT THE SURGICAL SITE. PATIENT REACHED OUT TO HER SURGEON AND WILL BE GOING TO THE HOSPITAL ER ON (B)(6) 2024 TO HAVE IT EVALUATED.

  Patient problems: Burning Sensation; Fluid Discharge; Insufficient Information; Skin Discoloration

  MAUDE report 18613399 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE OF A VENTRALIGHT ST W/ ECHO PS IN UMBILICAL HERNIA REPAIR, "THE FILL TUBE FOR THE BALLOON BROKE INSIDE THE BODY.¿ AS REPORTED THE SURGEON WAS ¿ABLE TO RETRIEVE THE BROKE LOOP WITH A GRASPER.¿ THE MESH WAS ABLE TO BE IMPLANTED AND THERE WAS NOT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607570 ↗
• InjuryMar 1, 2023Defective 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 UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2016 AND (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. 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: Insufficient Information; Pain

  MAUDE report 16459761 ↗
• InjuryFeb 8, 2023Defective 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 VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. 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; Pain; Scar Tissue

  MAUDE report 16319250 ↗
• InjuryJan 3, 2023Break; Break

  AS REPORTED ON (B)(6) 2022 WHILE REMOVING THE ECHO PS INFLATION ASSEMBLY FOLLOWING IMPLANT OF THE VENTRALIGHT ST MESH THE INFLATION TUBE BROKE AND A PORTION OF THE INFLATION TUBE WHICH INCLUDED THE YELLOW ANCHOR WAS LEFT IN THE PATIENT¿S ABDOMEN. IT WAS REPORTED THAT THE SURGEON DID NOT CUT THE INFLATION TUBE AT THE SKIN LEVEL BELOW THE YELLOW ANCHOR PRIOR TO REMOVING THE ECHO PS INFLATION ASSEMBLY. THE SURGEON ATTEMPTED TO RETRIEVE THE PIECE OF INFLATION TUBE USING A SUCTION IRRIGATOR; HOWEVER, WAS UNSUCCESSFUL AND THE PIECE WAS LEFT IN VIVO.

  Patient problems: Foreign Body In Patient

  MAUDE report 16087310 ↗
• MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022 USING THE BARD/DAVOL VENTRALIGHT ST W/ECHO PS AFTER FIXATING THE MESH AND REMOVING THE BALLOON IT WAS NOTED THAT ONE OF THE CONNECTORS WAS MISSING. IT WAS REPORTED THAT THE SURGEON SEARCHED FOR THE CONNECTOR BUT, COULD NOT FIND THE MISSING COMPONENT AND BELIEVES THAT IT REMAINS IN THE PATIENT. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15968762 ↗
• MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022. THE BARD/DAVOL VENTRALIGHT ST W/ECHO PS MESH WAS USED. AS REPORTED, THE SURGEON REMOVED THE ECHO PS BALLOON AFTER FIXATING THE MESH AND THE OR TEAM FOUND THAT ONE CONNECTOR WAS MISSING. IT WAS REPORTED THAT THE SURGEON THEN NOTICED THE COIL SLIGHTLY STICKING OUT OF THE MESH AND REMOVED IT WITH A GRASPER SUCCESSFULLY. AS REPORTED, THE SURGEON GRASPED THE BALLOON AT THE DARK ARROW MARKED ON THE BALLOON AND PULLED AS DIRECTED. AS REPORTED, THERE WAS NO PATIENT HARM OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968681 ↗
• InjuryNov 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A ROBOTIC UMBILICAL HERNIA REPAIR ON (B)(6) 2022, A VENTRALIGHT ST MESH W/ECHO PS WAS IMPLANTED THROUGH 12MM TROCAR TO THE PATIENT. IT IS REPORTED THAT AFTER INSERTION, WHEN THE SURGEON WAS PULLING THE INFLATION TUBE UP THROUGH THE ABDOMINAL WALL SKIN INCISION, THE INFLATION TUBE BROKE, AND THE YELLOW ANCHOR GOT STUCK IN THE PATIENT'S FASCIA. AS REPORTED, THE SURGEON WAS ABLE TO INFLATE THE ECHO PS AND FIXATE THE MESH WITHOUT ANY ISSUES; HOWEVER, AFTER THEY REMOVED THE ECHO PS ONCE THE MESH WAS FIXATED, THEY NOTICED THE YELLOW ANCHOR WAS MISSING SO THE SURGEON MADE AN EXTENSION OF THE SKIN INCISION TO RETRIEVE THE YELLOW ANCHOR AND PIECE OF INFLATION TUBE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829687 ↗
• InjuryOct 19, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH NON-BARD/DAVOL MESH TO REPAIR AN UMBILICAL HERNIA. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT PARTIAL REMOVAL OF THE NON-BARD/DAVOL MESH AND ALSO UMBILICAL HERNIA REPAIR DURING WHICH THE BARD/DAVOL VENTRALIGHT ST W/ECHO WAS IMPLANTED. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE MESH PRODUCTS. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, DENSE ADHESIONS, RECURRENCE, AND SURGERY TO REMOVE MESH. IT IS ALLEGED THAT THE VENTRALIGHT ST W/ECHO MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND SUFFERING, AS WELL AS MENTAL ANGUISH AND EMOTIONAL DISTRESS. ATTORNEY ALLEGES THAT "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 DEVICE WAS D

  Patient problems: Adhesion(s); Hernia; Inflammation; Pain

  MAUDE report 15630374 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2016 - SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT ROBOTIC-ASSISTED PROCEDURE FOR INCARCERATED, VENTRAL, INCISIONAL HERNIA REPAIR AT THE LLQ. THE SIZE OF THE HERNIA DEFECT WAS 3CM X 3CM. A BARD/DAVOL VENTRALIGHT ST WAS PLACED USING ECHO PS AND WAS FIXATED WITH SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016. (B)(6) 2016 - SUBJECT PATIENT PRESENTED WITH A "LARGE BULGE" (SEROMA) DURING THE 1ST POST-OP VISIT. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE REPORTED AE HAS RESOLVED. (B)(6) 2017 - FOLLOW UP APPOINTMENT, ULTRASOUND-GUIDED ASPIRATION WAS ORDERED. PER ULTRASOUND LARGE HERNIA WITHOUT FLUID. NO ASPIRATION ATTEMPTED. THE PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERING/RESOLVING.

  Patient problems: Seroma

  MAUDE report 14490426 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2016 - SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT ROBOTIC-ASSISTED PROCEDURE FOR INCARCERATED, VENTRAL, INCISIONAL HERNIA REPAIR AT THE LLQ. THE SIZE OF THE HERNIA DEFECT WAS 3CM X 3CM. A BARD/DAVOL VENTRALIGHT ST WAS PLACED USING ECHO PS AND WAS FIXATED WITH SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016. (B)(6) 2016 - SUBJECT PATIENT PRESENTED WITH A "LARGE BULGE" (SEROMA) DURING THE 1ST POST-OP VISIT. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE REPORTED AE HAS RESOLVED. (B)(6) 2017 - FOLLOW UP APPOINTMENT, ULTRASOUND-GUIDED ASPIRATION WAS ORDERED. PER ULTRASOUND LARGE HERNIA WITHOUT FLUID. NO ASPIRATION ATTEMPTED. THE PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERING/RESOLVING.

  Patient problems: Hernia

  MAUDE report 14490215 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014: SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED FIRST TIME RECURRENT MIDLINE HERNIA REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRALIGHT ST WITH ECHO PS WAS IMPLANTED USING UNSPECIFIED SUTURES. SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2018: SUBJECT PATIENT WAS PRESENTED WITH BULGE AND DISCOMFORT. ON (B)(6) 2018: CT SCAN CONFIRMED RECURRENT VENTRAL INCISIONAL HERNIA. ON (B)(6) 2018: SUBJECT PATIENT UNDERWENT AN REOPERATION FOR HERNIA RECURRENCE AND DURING THE PROCEDURE, THE MESH WAS PARTIALLY REMOVED (35%) AND ANOTHER VENTRALIGHT ST W/ECHO PS WAS IMPLANTED. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hernia

  MAUDE report 14489665 ↗
• InjuryMay 24, 2022Defective Device; Patient Device Interaction Problem; Material Split, Cut or Torn; Defective Device; Patient Device Interaction Problem; Material Split, Cut or Torn

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. 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; Pain

  MAUDE report 14484941 ↗