Symbotex SYM12FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521190351), received between Feb 11, 2019 and Apr 27, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, POST-OPERATIVELY, THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE LEGS AND NIGHTTIME ELECTROCUTION-LIKE SENSATIONS IN THE LEGS THAT WERE INCREASING IN SEVERITY AND FREQUENCY.

  Patient problems: Neuropathy; Pain

  MAUDE report 24995296 ↗
• MalfunctionApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 4 DAYS POSTOPERATIVELY FROM A HERNIA REPAIR WITH MESH THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY. THE PATIENT REPORTS ABDOMINAL PAIN DESCRIBED AS RADIATING, STABBING, AND ELECTRIC SHOCK-LIKE, ALONG WITH HIVES ON SCARS, DISABLING DAILY PAIN, AND MOBILITY PROBLEMS. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Insufficient Information; Scar Tissue

  MAUDE report 24947705 ↗
• MalfunctionMar 9, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA PROCEDURE, UPON FIXATING THE MESH TO THE ABDOMINAL WALL, FOUR TACKS PENETRATED THROUGH THE MESH AND TORE THREADS OF MESH, WHICH RESULTED TO THE MESH NOT FIXATING TO THE ABDOMINAL WALL. MORE TACKS WERE DEPLOYED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551979 ↗
• MalfunctionOct 19, 2023Loss of or Failure to Bond; Material Split, Cut or Torn; Loss of or Failure to Bond; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH ABDOMINAL INCISIONAL HERNIA SURGERY, THE FIRST TWO FIRINGS FROM THE TACKER WERE PERFORMED NORMALLY. FROM THE THIRD TO THE SIXTH FIRING, THERE WAS PENETRATION THROUGH THE MESH BUT FIXATION COULD NOT BE PERFORMED NORMALLY. THIS RESULTED TO DAMAGE FROM THE MESH. THE ONES THAT PENETRATED THE ABDOMINAL WALL AND PENETRATED THE MESH WERE RETAINED INSIDE THE BODY BECAUSE THERE WAS A HIGH POSSIBILITY OF BLEEDING IF TACKS WERE FORCIBLY REMOVED. FROM THE SEVENTH FIRING ONWARDS, MESH COULD BE FIXATED NORMALLY SO THE MESH WAS STILL KEPT INSIDE THE PATIENT. SINCE THE ISSUE LED TO INSUFFICIENT TACKS, A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966890 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC BARIATRIC REVISION PROCEDURE, MESH ADHESIONS ON BOWEL WERE FOUND FROM VENTRAL HERNIA REPAIR AND SLEEVE GASTRECTOMY PERFORMED IN 2019. THE PATIENT WAS REQUIRED 20-30 MINS OF ADHESIOLYSIS. ADHESIONS ON INFERIOR EDGE OF MESH WERE DISSECTED. BOWEL WAS REMOVED FROM MESH AND SOME PARTS OF MESH CUT AWAY. TISSUE DAMAGE AND TISSUE LOSS WERE NOTED. THE SURGICAL TIME WAS ALSO EXTENDED FOR 30 MINUTES OR MORE AND PATIENT HOSPITALIZATION WAS EXTENDED AS WELL.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 14569759 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE FROM LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) FOR UMBILICAL HERNIA, DIRECTLY AFTER T HE SURGERY, THE PATIENT ALWAYS COMPLAINED OF PAIN, WHICH WAS EXPLAINED BY THE SURGEON AS DUE TO THE FIXATION. HOWEVER, EVEN AFTER THE YEAR THE PAIN DID NOT DISAPPEAR AND ONLY INCREASED SO THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND STAYED IN THE HOSPITAL FOR 4 1/2 WEEKS. CT WAS MADE AND INFLAMMATION BETWEEN ABDOMINAL WALL AND MESH WAS DETECTED. REPEAT LAPAROSCOPY WAS PERFORMED. DUODENITIS AND GASTRITIS WERE ALSO DETECTED. THE EVENT LED TO INFLAMMATION AND PAIN. THE CONDITION IMPROVED AFTER ANTIBIOTICS BUT THERE WAS STILL PAIN IN MESH AREA.

  Patient problems: Inflammation; No Code Available; Pain; Radiation Exposure, Unintended

  MAUDE report 8511595 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING SCAR HERNIOTOMY, AN INTRAPERITONEAL ONLAY MESH (IPOM) WAS IMPLANTED ON THE PATIENT. A SECOND SURGERY WAS PERFORMED BUT IT WAS DUE TO ADHESIONS SO THE MESH WERE LEFT INSIDE. THE PATIENT THEN HAD CHRONIC ABDOMINAL SCAR PAIN, INFECTION OF THE IPOM AND LIGHT-GRADED SECRETION AT THE UMBILICUS. THE MESH WAS EXPLANTED BY MEDIAN LAPAROTOMY AND THE PATIENT WAS PRESCRIBED WITH NEEDS-BASED ANALGESIA. THERE WAS NO FLORID SIGNS OF INFLAMMATION IN THE MATERIAL WHICH WAS SENT IN. IT WAS A PRONOUNCED FOREIGN BODY REACTION. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS.

  Patient problems: Abdominal Pain; No Code Available; Unspecified Infection

  MAUDE report 8325120 ↗