Symbotex SYM2015FRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521190665), received between Apr 10, 2019 and Apr 6, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH PLACEMENT OF A MESH PROSTHESIS, THE INDIVIDUAL EXPERIENCED INTENSE PAIN, TIGHTNESS, TRANSIT PROBLEMS, BLOATING, FATIGUE, PAIN WITH CERTAIN MOVEMENTS, ABDOMINAL STIFFNESS AFTER MEALS, STABBING PAIN ON BOTH THE RIGHT AND LEFT SIDES ACCENTUATED BY EATING OR WALKING, INABILITY TO SLEEP ON THE SIDE DUE TO DISCOMFORT AND PAIN FROM RUBBING, AND DISABLING PAIN IMPACTING DAILY LIFE. THE INDIVIDUAL REPORTED LOSS OF EMPLOYMENT DUE TO INCAPACITY AND WAS RECOGNIZED AS A WORKER WITH DISABILITY STATUS.

  Patient problems: Abdominal Cramps; Ambulation or Postural Difficulties; Discomfort; Fatigue; Pain

  MAUDE report 24794120 ↗
• InjuryFeb 21, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2021, THE PATIENT HAD PERSISTENT PAIN FOLLOWING WHITE LINE VENTRAL HERNIA REPAIR WITH ABDOMINAL WALL MESH. VERY SEVERE POST-PROCEDURE PAIN THAT HAS IMPROVED OVER TIME BUT PERSISTED. A PERSISTENT PAIN ASSESSMENT WAS PERFORMED ON (B)(6) 2021, I.E., 10 MONTHS AFTER SURGERY FOR MESH PLACEMENT. ABDOMINAL-PELVIC COMPUTED TOMOGRAPHY SCAN AFTER CONTRAST INJECTION WITH NO ABNORMALITY VISUALIZED. CURRENTLY, THE PATIENT STILL HAS PERSISTENT ABDOMINAL PAIN: PAIN AND/OR DISCOMFORT DURING PROLONGED SITTING. SOMETIMES UNCOMFORTABLE LATERAL SUPINE POSITION. PAIN AND/OR DISCOMFORT WITH LARGE MEALS. PAIN AND/OR DISCOMFORT WHEN EXERCISING (RUNNING, YOGA, MUSCLE STRENGTHENING). TROUBLE-TO-WEAR PANT BELT FOR ALL-DAY WEAR.

  Patient problems: Abdominal Pain; Discomfort; Unintended Radiation Exposure

  MAUDE report 24410430 ↗
• InjuryDec 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF AN INTRAPERITONEAL ONLAY MESH (IPOM) PLUS LAPAROSCOPIC VENTRAL HERNIA REPAIR NEAR THE UMBILICUS DONE ON (B)(6) 2021, THE PATIENT CAME BACK TO THE HOSPITAL PRESENTING A HERNIA RECURRENCE. THE PATIENT WAS RE-OPERATED ON (B)(6) 2025 AND IT WAS SEEN THAT THE MESH HAD A HOLE IN THE MIDDLE. THE MESH WAS NOT EXPLANTED.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 23766947 ↗
• InjuryDec 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE LAPAROSCOPIC HERNIA PROCEDURE INVOLVING A MESH IMPLANT, A RECURRENCE OF THE ISSUE WAS OBSERVED, ALONG WITH A HOLE IN THE CENTER OF THE MESH. THE HERNIA WAS LOCATED VENTRALLY, AND THE MESH HAD BEEN IMPLANTED IN (B)(6) 2022. A LAPAROTOMY WAS PERFORMED TO EXPLANT THE MESH, AND AN ADDITIONAL MESH WAS REQUIRED TO CORRECT THE ISSUE.

  Patient problems: Hernia

  MAUDE report 21033673 ↗
• InjurySep 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, TWO MONTHS AFTER A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE TO REPAIR AN ABDOMINAL INCISIONAL HERNIA, THE MESH RUPTURED. TO RESOLVE THE ISSUE, AN EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) PROCEDURE WAS PERFORMED. THE INTRAP ERITONEAL CAVITY WAS INSPECTED, AND THE SUTURE WAS FOUND TO HAVE TORN INTO PIECES. THE WOUND WAS THEN OCCLUDED USING A TACKER TO SECURE THE PORT WOUND.

  Patient problems: Failure of Implant

  MAUDE report 20195163 ↗
• MalfunctionSep 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO MESH WERE DAMAGED, THE MATERIAL HAD A DEFECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849016 ↗
• MalfunctionSep 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO MESH WERE DAMAGED, THE MATERIAL HAD A DEFECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848509 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR, ON NORMAL USE AFTER IMPLANTATION, AFTER DISSECTION OF ADHESIONS TO THE INTRAPERITONEAL ONLAY MESH REPAIR PREVIOUSLY PLACED ON PATIENTS ABDOMEN AT THE ORIGINAL SITE OF AN OPEN CHOLECYSTECTOMY, THE SURGEON NOTED THAT THE ORIGINAL MESH IMPLANTED HAD SPLIT AND A RECURRENT HERNIA HAD DEVELOPED. THE PREVIOUS CHOLECYSTECTOMY WAS PERFORMED OPEN, THE PRIMARY AND RECURRENT HERNIA REPAIR WAS PERFORMED LAPAROSCOPICALLY. THE DAMAGED MESH WAS LEFT IN PLACE. A SECOND PIECE OF MESH WAS PLACED OVER THE TOP. THE LAPAROSCOPIC PORT INCISIONS CREATED IN THE PATIENT¿S ABDOMEN FOR THE RECURRENT HERNIA REPAIR TO BE PERFORMED WAS EXTENDED. THE PATIENT EXPERIENCED TISSUE DAMAGE AS A RESULT. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES AND THE EVENT HAS LEAD TO PATIENT HOSPITALIZATION FOR FOUR DAYS. IT WAS ALSO STATED THAT THERE WAS NO MALFUNCTION WITH THE TACKERS, IT WAS REPORTED AS PART OF THE SYSTEM USED TO REPAIR THE PRIMARY HERNIA AND RECURRENT HERNIA REPAIRS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15202170 ↗
• InjuryJun 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING A VENTRAL HERNIA REPAIR IN 2018, THE PATIENT HAD FELT PAIN WHICH WAS SIMILAR TO THE ORIGINAL HERNIA. THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION FOR THE PAIN AND IT WAS FOUND THAT THERE WERE ADHESIONS TO THE MESH. NO MESH WAS IN THE REMOVED ADHESION BUT DISSECTION OF THE MESH REVEALED TWO HOLES IN THE CENTER OF THE MESH. ADDITIONAL MESH WAS PLACED OVER THE HOLE IN THE EXISTING MESH. THE SURGICAL TIME WAS EXTENDED AND THE PATIENT WAS ANESTHETIZED FOR 40 ADDITIONAL MINUTES.

  Patient problems: Adhesion(s); No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 10161338 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn

  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 A RECURRENT VENTRAL ABDOMINAL WALL HERNIA WITH SMALL INTESTINE THAT HADMIGRATED THROUGH A HOLE IN THE MIDDLE OF THE MESH. THE INTESTINES WERE TRAPPED AND HAD SIGNS OF SUFFUSIONS/HYPEREMIA. THERE WERE ALSO POST-OPERATIVE COMPLAINTS IN THE RIGHT UPPER ABDOMEN WITH INCREASE OF INFLAMMATORY VALUES. POST-IMPLANT TREATMENT INCLUDED TWO REVISION SURGERIES, WITH CLOSURE OF THE HOLE AND IMPLANT OF NEW MESH. IT WAS NOTED DURING THE FIRST REVISION THAT THE MESH WAS CORRECTLY FIXATED WITH USUAL GROW-IN BETWEEN THE PERITONEUM AND THE ABDOMINAL WALL.

  Patient problems: Abdominal Distention; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Fatigue; Fungal Infection; Hematoma; Hernia; Hyperemia; Inflammation; Injury; Nausea; No Code Available; Pain; Perforation; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9290640 ↗
• MalfunctionApr 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE SURGEON HAD ROLLED THE MESH UP TO PUT DOWN THE PORT AND AS HE WAS TRYING TO GET IT DOWN THE 11MM PORT WITH HIS GRASPERS, THE MESH TORN AND GOT A HOLE IN IT. THE DEFECT WAS APPROXIMATELY AROUND 10CM. THE SURGEON INCREASED PORT SIZE TO 15MM AND USED ANOTHER MESH TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500113 ↗