Symbotex SYM3020OSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521190535), received between Apr 9, 2019 and Apr 8, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BULGING, RECURRENCE, INFLAMMATION, PAIN, ALLERGIC REACTION, ADHESIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 19066751 ↗
• InjuryFeb 14, 2024Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, FISTULA, INFECTION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Fistula; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 18707179 ↗
• InjuryJun 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, ADHESIONS, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH ANASTOMOSIS.

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

  MAUDE report 17087253 ↗
• InjuryDec 14, 2021Mechanics 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL AND PHYSICAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, MESH FAILED, INFECTION, ABSCESS, RECURRENCE, CHRONIC NON-HEALING WOUND, DRAINING PURULENT MATERIAL, SEROUS FLUID, ULCER. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, REVISION SURGERY, INCISION, DRAINAGE, DEBRIDEMENT OF ABSCESS, INCISION DRAINAGE OF NONHEALING ABDOMINAL WOUND, WOUND EXPLORATION, MESH TRIMMED.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Fluid Discharge; Hernia; Impaired Healing; Pain; Purulent Discharge; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12994496 ↗
• InjuryJun 18, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, AND MESH REMOVAL.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 12026727 ↗
• InjuryApr 30, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, SUFFERING, SCARRING, INFLAMMATION, FOREIGN BODY RESPONSE, MESH FAILURE, PAIN, HERNIA RECURRENCE, EVENTRATION, RIGHT FLANK BULGING, ADHESIONS, PERMANENT IMPAIRMENT, DISABILITY, AND LOSS OF ENJOYMENT OF LIFE, AND FROZEN ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MESH REVISION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrophy; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11753191 ↗
• InjuryNov 18, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ANTERIOR COMPONENT SEPARATION AND RELEASE OF ABDOMINAL WALL.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 10860806 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPEN HERNIA SURGERY, PATIENT DEVELOPED WALL ABSCESS AND WAS RE-HOSPITALIZED. THE MESH WITH LOWER HEMATOMA WAS OPENED AND CONTINUOUS SUCTION SYSTEM IS PLACED DUE TO THE BAD APPEARANCE OF THE WALL. FISTULA WAS NOTED ON (B)(6) 2019 AND PATIENT UNDERWENT REOPERATION AND VACUUM-ASSISTED CLOSURE WAS CHANGED. THE MESH WAS RESECTED AND RESECTION OF THE FISTULA WITH PRIMARY CLOSURE OF THE MESH WITH 15 CM BOWEL RESECTION WAS DONE ON (B)(6) 2019. THIS CAUSED TISSUE LOSS.

  Patient problems: Abscess; Fistula; Hematoma; No Code Available; Tissue Damage

  MAUDE report 9786102 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN PARACOLOSTOMY HERNIA, THE PATIENT HAD TO RETURN TO THE HOSPITAL DUE TO ENTEROCUTANEOUS FISTULA. THIS RESULTED TO TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS. RE-OPERATION, FISTULA TREATMENT AND ILEOSTOMY WERE MADE TO COMPETE THE CASE. THE PATIENT STILL HOSPITALIZED.

  Patient problems: Fistula; No Code Available; Tissue Damage

  MAUDE report 9786042 ↗
• InjuryApr 9, 2019Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A COMPLEX RECURRENT INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, MESH MIGRATION, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFECTED MESH, OPEN WOUND A LOOP OF BOWEL THAT WAS VERY ADHERENT TO MESH AND COULD NOT BE SEPARATED WITHOUT CAUSING AN ENTEROTOMY, AND ADHESIONS. POST-OPERATIVE TREATMENT INCLUDED LYSIS OF ADHESIONS, REVISION SURGERY WITH LIFECELL STRATTICE MESH, SMALL BOWEL RESECTION, AND EXCISION OF INFECTED MESH.

  Patient problems: Adhesion(s); Emotional Changes; Erosion; Hernia; Impaired Healing; Inflammation; Injury; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8495217 ↗