Symbotex SYM9Recalls & reported problems

Summary

The FDA's MAUDE database contains 354 adverse event reports that list this exact device (DI 10884521190634), received between Sep 19, 2017 and Sep 24, 2026 — classified as 2 deaths, 349 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (195 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 354 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse 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 implant, the patient experienced emotional distress, hernia recurrence, adhesions, pain, & suffering. Post-operative patient treatment included revision surgery, lysis of adhesions, & hernia repair.

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

  MAUDE report 50886146 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient¿s attorney alleged a deficiency against the device. The product was used for a laparoscopic therapeutic treatment of a umbilical hernia. It was reported that after implant, the patient experienced pain, hernia recurrence, adhesions, seroma, swelling, difficulty going to restroom (may not be able to go for up to a week), scarring, mental instability based on looks/appearances. Post-operative patient treatment included medication.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 50008719 ↗
• InjuryJun 2, 2026Adverse 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, HAD A HARD TIME WITH BOWEL MOVEMENTS, DEFECTIVE MESH, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, OPEN BILATERAL RECTUS MYOFASCIAL ADVANCEMENT FLAPS, OPEN BILATERAL TRANSVERSUS ABDOMINIS MYOFASCIAL ADVANCEMENT FLAPS, RESECTION OF SKIN AND TISSUE, LYSIS OF ADHESIONS AND MESH REVISION.

  Patient problems: Adhesion(s); Distress; Hernia; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 25364963 ↗
• InjuryJun 2, 2026Adverse 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.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25364562 ↗
• DeathMay 26, 2026Adverse 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 A VENTRAL & PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, INFECTION, ABSCESS, FISTULA, PAIN, SUFFERING, MESH NOT INCORPORATED AND FLOATING IN PURULENCE, CHRONIC OPEN WOUND, HERNIA RECURRENCE, & DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAP, REMOVAL OF INFECTED MESH, EXCISION DEBRIDEMENT OF SUBCUTANEOUS TISSUES, BOWEL RESECTION, WOUND CARE, HOSPITALIZATION, & ADDITIONAL SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Abscess; Distress; Fistula; Hernia; Impaired Healing; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25279282 ↗
• InjuryMay 11, 2026Adverse 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 EMOTIONAL DISTRESS, PAIN AND SUFFERING.

  Patient problems: Distress; Pain; Unspecified Tissue Injury

  MAUDE report 25144221 ↗
• InjuryNov 20, 2025Adverse 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 PAIN, RECURRENCE, ADHESIONS, FLATUS, ABDOMINAL PAIN, HEMORRHOIDS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23607625 ↗
• InjuryNov 17, 2025Adverse 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 IMPLANT, THE PATIENT EXPERIENCED FISTULA, PAIN, RECURRENCE AND OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED COLECTOMY AND REMOVAL OF COLOCUTANEOUS FISTULA, REVISION OF TRANSVERSE LOOP COLOSTOMY, MEDICATION.

  Patient problems: Fistula; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 23576646 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, EMOTIONAL CHANGES, DISCOMFORT, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23536698 ↗
• DeathNov 4, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Distress; Fistula; Fluid Discharge; Fungal Infection; Obstruction/Occlusion; Pain; Perforation; Septic Shock; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23468065 ↗
• InjuryNov 3, 2025Adverse 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 AND INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23457656 ↗
• InjuryOct 1, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, OBSTRUCTION, RECURRENCE, PAIN, SUFFERING, DEFECTIVE MESH, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, USE OF BLAKE DRAIN, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23196663 ↗
• InjurySep 30, 2025Adverse 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Distress; Pain; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 23182280 ↗
• InjurySep 15, 2025Adverse 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 EMOTIONAL DISTRESS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, MESH REMOVAL.

  Patient problems: Distress; Pain; Unspecified Tissue Injury

  MAUDE report 23055883 ↗
• InjuryJul 18, 2025Adverse 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 LEFT FLANK HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SEROMA, INCARCERATION, CHRONIC INFLAMMATION, FOREIGN BODY GIANT CELLS, AND HARDNESS AROUND SURGERY SITE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL SURGERY, AND HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Abdominal Distention; Foreign Body Reaction; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 22549453 ↗
• InjuryJul 7, 2025Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22423917 ↗
• InjuryJul 2, 2025Adverse 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, INFECTION, RECURRENCE, ABSCESS, OPEN WOUND, AND MUSCLE SPASMS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, EXCISIONAL DEBRIDEMENT OF TISSUE, AND WOUND VAC.

  Patient problems: Abscess; Cramp(s) /Muscle Spasm(s); Hernia; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22387483 ↗
• InjuryJun 30, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, RECURRENCE, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22360125 ↗
• InjuryJun 12, 2025Adverse 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 AND ADHESIONS.

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

  MAUDE report 22196025 ↗
• InjuryJun 2, 2025Adverse 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 PULMONARY COLLAPSE, PARALYTIC ILEUS, HYPOPOTASSEMIA, DISORDER MAGNESIUM METABOLISM, ABNORMAL REACTION, AND DIGESTIVE SYSTEM COMPLICATIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electrolyte Imbalance; Foreign Body Reaction; Hypokalemia; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 22127656 ↗
• InjuryMay 23, 2025Adverse 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 PAIN, RECURRENCE, ADHESIONS, AND FREQUENT BLOCKAGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 22080212 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST-OPERATIVELY ROBOTIC UMBILICAL HERNIA, THE PATIENT RETURNED TO THE EMERGENCY ROOM AFTER SURGERY WITH BOWEL ADHESIONS TO THE MESH AND OBSTRUCTIONS.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 22076371 ↗
• InjuryMay 19, 2025Adverse 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, INCARCERATED OMENTUM AGAINST THE MESH, INFECTION, HEMATOMA, INFLAMMATION, OBSTRUCTIONS, BLEEDING, FISTULAS, PULLING SENSATION, WEIGHT LIFTING RESTRICTIONS, CHRONIC INTERMITTENT DIARRHEA AND CONSTIPATION, URINARY RETENTION, URINARY INCONTINENCE, AND OVERACTIVE BLADDER. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MEDICATION.

  Patient problems: Adhesion(s); Constipation; Diarrhea; Discomfort; Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 22045953 ↗
• InjuryMay 16, 2025Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 MESH PULLED INTO DEFECT, DEFECTIVE MESH, RECURRENCE, ABDOMINAL PAIN, BULGING, INFLAMMATION, DISCOMFORT, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 22037682 ↗
• InjuryMay 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION, AND LYSIS OF ADHESIONS.

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

  MAUDE report 21964263 ↗