Symbotex SYM8OSRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521190627), received between Feb 24, 2018 and Jun 5, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH ANASTOMOSIS, WOUND VAC, HERNIA REPAIR.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22153356 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, TENDER TO TOUCH, AND SOMETIMES UNABLE TO EAT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 20929110 ↗
• InjuryMay 17, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, INFECTION, RECURRENCE, ADHESIONS, SEROMA, INFLAMMATION, SCARRING, NERVE DAMAGE, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16948140 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND HERNIA RECURRENCE.

  Patient problems: Abdominal Pain; Hernia; Unspecified Tissue Injury

  MAUDE report 12414549 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION/PROBLEMS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 11527446 ↗
• InjurySep 24, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, SEROSAL SUPPURATIVE EXUDATE ON SMALL BOWEL, INFECTION, ABSCESS, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Inflammation; Injury; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10583920 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, ABDOMINAL PAIN, SMALL BOWEL OBSTRUCTION AS A RESULT OF MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION X2 WITH PRIMARY ANASTOMOSIS, LYSIS OF ADHESIONS, AND PLACEMENT OF ABTHERA VACUUM TEMPORARY ABDOMINAL CLOSURE.

  Patient problems: Abdominal Pain; Adhesion(s); Failure of Implant; Hernia; Injury; Obstruction/Occlusion

  MAUDE report 9738150 ↗
• InjuryApr 17, 2019Material Erosion; Material Erosion

  ACCORDING TO THE REPORTER, DURING A VENTRAL HERNIA PROCEDURE, THE SURGEON NOTED THAT THE MESH WAS DEFECTIVE DUE TO THE FAT WAS PROTRUDING THROUGH THE MESH WHEN IT WAS SEWN INTO THE ABDOMINAL WALL. REMOVED THE REPORTED MESH AND REPLACED WITH A NEW A DEVICE. IT WAS SUTURED AND THE SKIN WAS STAPLED BACK TOGETHER. THE SURGICAL TIME WAS EXTENDED 45 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8523296 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN EPIGASTRIC INCARCERATED VENTRAL INCISIONAL HERNIA AS WELL AS A PERIUMBILICAL VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC ABDOMINAL PAIN, ADHESIONS TO SMALL BOWEL AND MESH AS WELL AS INFERIOR TO MESH, THERE WAS PART OF THE OMENTUM THAT WAS INFARCTED, NECROTIC AND INFLAMED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Inflammation; Injury; Necrosis; No Code Available

  MAUDE report 8469861 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA BY LAPAROSCOPIC REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, UMBILICAL PAIN, BULGE IN UMBILICAL REGION, AND ADHESIONS TO ANTERIOR WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED RECURRENT UMBILICAL HERNIA REPAIR WITH COVIDIEN MESH AND LYSIS OF ADHESIONS. RELEVANT TESTS/LABORATORY DATA B6: 01MAY2017: PER OP NOTE, IMAGING STUDY SHOWED A RECURRENT BULGE IN THE UMBILICAL REGION.

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

  MAUDE report 8469248 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED POSSIBLE SURGICAL INTERVENTION.

  Patient problems: Injury

  MAUDE report 8438332 ↗
• InjuryDec 2, 2018Material Erosion; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF INCARCERATED INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, DRAINAGE, FISTULA, EROSION, SEVERE PAIN, LOSS OF APPETITE, INFLAMMATION, BOWEL INJURY, ADHESIONS, MESH MIGRATION, FAILURE OF MESH, SCARRING, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND WEIGHT LOSS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION, RESECTION OF FISTULA, CECAL VAULT REPAIR, MESH INTERVENTION SURGERY, AND RESECTION OF INFECTED MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Emotional Changes; Erosion; Fistula; Fluid Discharge; Inflammation; Injury; No Code Available; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 8123215 ↗
• InjuryOct 5, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE ADHESIONS, BOWEL ADHESION, MESH "ROLLED-UP", ABDOMINAL WALL HEMATOMA, CHRONIC ACUTE BLOOD LOSS, ANEMIA, BILATERAL SIMPLE RENAL CYST, SEVERE PAIN, INABILITY TO WORK, NAUSEA, SCARRING AND DISFIGUREMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL EXCISION, FASCIA DEBRIDEMENT, CONSIDER REPEAT ULTRASOUND IN 6-12 MONTHS AND MONITORING KIDNEY FUNCTION.

  Patient problems: Adhesion(s); Anemia; Blood Loss; Cyst(s); Deformity/ Disfigurement; Disability; Hematoma; Injury; Nausea; No Code Available; Pain; Scarring

  MAUDE report 7937449 ↗
• InjuryAug 8, 2018Defective Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury; No Code Available

  MAUDE report 7762780 ↗
• InjuryJul 12, 2018Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, LIVER ADHESIONS, EXCISION AND RECURRENCE. AFTER TREATMENT, THE PATIENT EXPERIENCED REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Foreign Body Reaction; Hernia; Injury; No Code Available; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 7681810 ↗
• InjuryJul 11, 2018Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, LIVER ADHESIONS, EXCISION AND RECURRENCE . AFTER TREATMENT, THE PATIENT EXPERIENCED REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Foreign Body Reaction; Hernia; Injury; No Code Available; Pain; Scar Excision; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 7679162 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS UMBILICAL HERNIA. THE PROCEDURE PERFORMED WAS UMBILICAL HERNIA REPAIR USING MESH. THE PATIENT EXPERIENCED SURGICAL REVISION, AND INFECTION.

  Patient problems: Abscess; Adhesion(s); Injury; No Code Available; Purulent Discharge; Unspecified Infection

  MAUDE report 7294220 ↗