VENTRALIGHT 5955610Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741031748), received between Aug 18, 2017 and Dec 5, 2025 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 23730443 ↗
• MalfunctionJun 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY WITH IMPLANT OF VENTRALIGHT ST W/ECHO USING SORBAFIX ENHANCED FIXATION DEVICE ON (B)(6) 2020. AS REPORTED POST PROCEDURE PATIENT IS EXPERIENCING CHRONIC PAIN.

  Patient problems: Pain

  MAUDE report 22293135 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2018 - SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED MIDLINE SUBXYPHOID, EPIGASTRIC, AND UMBILICAL FIRST-TIME RECURRENT HERNIA (15X7 CM) REPAIR PROCEDURE. A VENTRALIGHT ST MESH WAS PLACED USING W/ECHO PS AND FIXATED USING A BARD/DAVOL OPTIFIX FIXATION DEVICE ALONG WITH NON-BARD/DAVOL PROLENE AND V-LOC SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND WAS HOSPITALIZED. (B)(6) 2018 - THE AE RESOLVED, THE PATIENT WAS DISCHARGED. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD 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: Obstruction/Occlusion

  MAUDE report 14461911 ↗
• InjuryMar 20, 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 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 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 13829763 ↗
• InjuryFeb 21, 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 VENTRALIGHT ST ON (B)(6) 2015. 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: Adhesion(s); Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 13566627 ↗
• InjuryAug 3, 2021Defective 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 MESH (BARD FLAT MESH) ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 12272098 ↗
• InjuryJul 15, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

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

  MAUDE report 10281148 ↗
• InjuryJul 9, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2016. 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; Injury

  MAUDE report 10249971 ↗
• InjuryJul 8, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013. 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); Injury

  MAUDE report 10245094 ↗
• InjuryMar 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING A DIFFICULT LAPAROSCOPIC HERNIA REPAIR WITH A BARD VENTRALIGHT ST W/ ECHO PS, THEY WERE EXPECTING TO REPAIR ONE HERNIA BUT FOUND THERE WERE MANY. THE BARD MESH WAS GOING TO BE USED ACROSS THE MULTIPLE HERNIAS. IT WAS REPORTED THAT THE OBTURATOR DEVICE (INTRODUCER TOOL PROVIDED WITH THE ECHO PS) PENETRATED THE BOWEL ON MESH INSERTION. DUE TO CONTAMINATION IN THE AREA THE VENTRALIGHT ST MESH WAS REMOVED AND A PHASIX MESH WAS USED FOR REPAIR OF THE HERNIAS. THE SURGEON THEN PERFORMED A BOWL ANASTOMOSIS. AS REPORTED THE ABDOMINAL PRESSURE GAS WAS UP TO 8, WHEN NORMALLY THIS IS DONE AT 12 OR HIGHER, THE PORT WAS PLACED EXTREMELY LATERAL FROM THE MIDLINE AND THE SURGEON DID NOT PUT THE INTRODUCER TOOL IN UNDER CAMERA VISION. THE HOSPITAL IS INVESTIGATING THE EVENT AND HAVE NOT CLAIMED THE DEVICE IS AT FAULT.

  Patient problems: Bowel Perforation

  MAUDE report 9801735 ↗
• MalfunctionFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, ON (B)(6) 2020 THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH A BARD VENTRALIGHT ST W/ ECHO PS. THERE WERE TWO (2) 2CM DEFECTS, 8CM APART. WHEN THE SURGEON ATTEMPTED TO PULL THE INFLATION TUBING UP AND OUT OF THE ABDOMEN BY GRASPING THE RETRIEVAL LOOP (NEEDLE LOOP COMPLEX) USING A SUTURE PASSER THE RETRIEVAL LOOP SEPARATED FROM THE INFLATION TUBING. THE SURGEON THEN GRASPED THE INFLATION TUBING AND SUCCESSFULLY IMPLANTED THE MESH. ALL PIECES WERE REMOVED FROM THE BODY. AS REPORTED, THE OR TIME WAS EXTENDED ABOUT 5 MINUTES AND THERE WAS NO PATIENT INJURY. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION NEEDED AND THE MESH WAS SUCCESSFULLY IMPLANTED. IT IS REPORTED THAT THE DEVICE SAMPLE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9740831 ↗
• InjuryDec 30, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/ DAVOL VENTRALIGHT ST ON (B)(6) 2017 AND (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9530476 ↗
• InjuryDec 17, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT HAD SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/ DAVOL VENTRALIGHT ST MESH ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST MESH. IT IS ALSO ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9482025 ↗
• InjuryNov 27, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2012 OR (B)(6) 2016, THE PATIENT UNDERWENT SURGERY, WHICH INCLUDED IMPLANT OF THE FOLLOWING UNSPECIFIED BARD/DAVOL HERNIA MESH DEVICES; SEPRAMESH IP (DEVICE #1), VENTRALIGHT ST (DEVICE #2), AND VENTRIO ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP (DEVICE #1) AND VENTRALIGHT ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Injury

  MAUDE report 9382477 ↗
• InjuryOct 9, 2019Improper or Incorrect Procedure or Method; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9173039 ↗
• InjuryJul 25, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2017: THE PATIENT UNDERWENT AN EPIGASTRIC HERNIA REPAIR. A BARD VENTRALIGHT ST (DEVICE #1) WAS IMPLANTED DURING THIS REPAIR. ON (B)(6) 2017: THE PATIENT WAS HOSPITALIZED FOR COMPLICATIONS. ON (B)(6) 2008: THE PATIENT UNDERWENT COLONOSCOPY REMOVAL OF (DESCRIPTION NOT PROVIDED). ON (B)(6) 2018: THE PATIENT UNDERWENT INCISION AND DRAINAGE OF SUPERFICIAL ABDOMINAL WALL ABSCESS. ON (B)(6) 2019: THE PATIENT UNDERWENT AN OPEN RETRORECTUS VENTRAL HERNIA REPAIR FURTHER SURGERY DUE TO COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH A BARD MESH (DEVICE #2). PATIENT CONTINUES TO SUFFER COMPLICATIONS, PERMANENT DISFIGUREMENT AND CHRONIC PAIN. THE BARD MESH IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE BARD MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE BARD MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN EMOTIONAL DISTRESS AND SEVERE PHYSICAL INJURIES. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AN

  Patient problems: Disability; Injury; Pain

  MAUDE report 8828673 ↗
• InjuryMay 16, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #1) ON (B)(6) 2014. AS REPORTED, THE PATIENT UNDERWENT SURGERY IN WHICH AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #2) WAS IMPLANTED ON (B)(6) 2014. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG (DEVICE #1) AND VENTRALIGHT ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 8617349 ↗
• InjuryMar 21, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2014. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALIGHT ST. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Scar Tissue

  MAUDE report 8441628 ↗
• MalfunctionOct 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018 TWO VENTRALIGHT ST MESH W/ ECHO PS DEVICES (DEVICE 1 AND DEVICE 2) WERE USED DURING A SURGICAL PROCEDURE. AS REPORTED TWO SEPARATE EVENTS OCCURRED DURING THIS PROCEDURE. IT WAS REPORTED THAT DURING PLACEMENT OF THE VENTRALIGHT ST MESH W/ ECHO PS (DEVICE 1), THE YELLOW ANCHOR CAME LOOSE FROM ITS FIXED POSITION AND SLID DOWN THE INFLATION TUBE. THE ANCHOR DID NOT FULLY DETACH FROM THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE MESH REMAINS IMPLANTED. IT WAS REPORTED THAT DURING PLACEMENT OF THE VENTRALIGHT ST MESH W/ ECHO PS (DEVICE 2), THE YELLOW ANCHOR DETACHED FROM ITS FIXED POSITION AND WAS LEFT IN VIVO AT THE CLOSE OF THE PROCEDURE. THERE WAS NO REPORTED MEDICAL INTERVENTION OR PATIENT HARM. THE MESH REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958239 ↗
• MalfunctionJun 11, 2018Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018 A VENTRALIGHT ST W/ ECHO PS WAS USED DURING A LAPAROSCOPIC REPAIR PROCEDURE. AS REPORTED WHILE REMOVING THE ECHO PS THROUGH THE TROCAR ONE OF THE CONNECTORS DETACHED FROM THE ECHO PS. IT WAS LOCATED AND RETRIEVED FROM THE PATIENTS ABDOMEN. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588943 ↗
• MalfunctionDec 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER INSTALLING THE VENTRALIGHT ST MESH AND REMOVING THE ECHO PS, THE DOCTOR FOUND A PIECE OF THE BALLOON MATERIAL IN THE ABDOMEN (LYING ON THE OMENTUM). PER HOSPITAL CONTACT THIS PIECE OF MATERIAL WAS NOTED WHILE PERFORMING A TAP BLOCK AT THE END OF THE CASE. THE DOCTOR EASILY REMOVED THE MATERIAL WITH A GRASPER THROUGH A 10/12 TROCAR WITHOUT ISSUE. CONTACT CONFIRMED THERE WAS NO PATIENT INJURY OR NEED FOR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084550 ↗
• MalfunctionAug 18, 2017Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6)2017 A BARD VENTRALIGHT ST W/ ECHO PS WAS BEING USED DURING A PROCEDURE. AS REPORTED DURING THE PROCESS OF REMOVING THE BALLOON THROUGH A 15MM PORT/TROCAR ONE OF THE CONNECTORS DETACHED FROM THE BALLOON AND WAS RETRIEVED FROM THE PATIENT¿S ABDOMEN. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803875 ↗