Symbotex SYM9FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521190641), received between Jul 21, 2019 and Feb 23, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A LAPAROSCOPIC SUPRAUMBILICAL HERNIA REPAIR USING THE INTRAPERITONEAL ONLAY MESH (IPOM) TECHNIQUE WITH MESH IMPLANTATION DESCRIBED PERSISTENT PAIN IN THE IMPLANT AREA WHEN SITTING, WHICH CONTINUED FOR EIGHT MONTHS AFTER SURGERY. THE PATIENT WAS FOR THREE MONTHS POST-SURGERY AND REPORTED REGULAR PAIN SINCE THE PROCEDURE. ADDITIONAL SYMPTOMS INCLUDED INABILITY TO LIFT MORE THAN 10 KG, SLOWED FECAL DISPOSAL, LIMITED FOOD INTAKE, THE ABILITY TO LIE DOWN ONLY ON THE BACK, AND INABILITY TO GET UP WITHOUT ASSISTANCE. THE HERNIA DEFECT WAS 1 CM IN SIZE AND LOCATED SUPRAUMBILICALLY. THE WOUND WAS CLOSED WITH SUTURES.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Feeding Problem; Implant Pain

  MAUDE report 24415565 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING LAPAROSCOPIC TREATMENT OF A WHITE LINE HERNIA WITH PREPERITONEAL PLACEMENT OF A MESH INTRAPERITONEAL PROSTHESIS, THE PATIENT EXPERIENCED PAIN IN THE STOMACH AND GROIN, STABBING-LIKE PAIN OR BURNING SENSATIONS, AND PERSISTENT DAILY PAIN. THE PATIENT ALSO PRESENTED WITH A SYMPTOMATIC SUPRAUMBILICAL HERNIA CHARACTERIZED BY PAINFUL SWELLING AND REPORTED A MORALLY AND PSYCHOLOGICALLY COMPLICATED SITUATION DUE TO FEAR OF CONDITION DETERIORATION. AN ULTRASOUND IDENTIFIED A HERNIA OF THE CENTIMETRIC SUPRAUMBILICAL WHITE LINE, AND A BLOOD TEST WAS CONDUCTED.

  Patient problems: Abdominal Pain; Implant Pain

  MAUDE report 24384416 ↗
• MalfunctionJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN LAPAROSCOPIC UMBILICAL HERNIA REPAIR USING A COMPOSITE PROSTHETIC REINFORCEMENT, THE PATIENT EXPERIENCED PERSISTENT PAIN AND PERMANENT DISCOMFORT, INCLUDED RADIATING PAIN FROM THE XIPHOID PROCESS TO THE SCROTUM (RIGHT TESTICLE), A WHITE LINE OVERHANGING THE ABDOMINAL WALL WHEN STANDING OR STRETCHING, DISCOMFORT WHEN SITTING AS IF THE TIP OF THE XIPHOID PROCESS PRESSED ON THE WHITE LINE, AND THE APPEARANCE OF A FLAT DIAMOND SHAPE AROUND THE XIPHOID PROCESS SUGGESTING DEVIATION OF THE UPPER ABDOMINAL MUSCLES FROM THE WHITE LINE. THE PATIENT REPORTED STRONG DISCOMFORT WHEN PALPATING AROUND THE PERIMETER OF THE MESH, DESCRIBED AS EQUIVALENT TO A "SIDE STITCH," POINTS OF PAIN AT THE LEVEL OF THE STAPLES, LOOSENING OF THE ABDOMINAL STRAP, AND A PERSISTENT BULGE AT THE BOTTOM OF THE NAVEL. ADDITIONAL SYMPTOMS INCLUDED INCREASED FREQUENCY OF SENSATIONS OF THE NEED TO URINATE, DISCOMFORT DURING URINATION, AND PAIN WHEN SITTING, ESPECIALLY WHEN THE FLOATING RIBS CONTACTED THE OPERATED AREA WHERE THE PROSTHESIS WAS LOCATED.

  Patient problems: Discomfort; Micturition Urgency; Pain

  MAUDE report 24220614 ↗
• MalfunctionJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY OF A UMBILICAL HERNIA PROCEDURE, THE MESH WAS ASSOCIATED WITH ALMOST PERMANENT PAIN, SEVERE FATIGUE, FEVER, REDUCED MOVEMENTS DUE TO PAIN, AND A VERY TIRED PATIENT.

  Patient problems: Extreme Exhaustion; Fever; Pain

  MAUDE report 24215008 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A SUPRA-UMBILICAL HERNIA REPAIR VIA DIRECT APPROACH WITH DIRECT SUTURE AND LAPAROSCOPIC APPROACH FOR PLACEMENT OF A 9 CM DIAMETER COMPOSITE INTRAPERITONEAL PROSTHETIC REINFORCEMENT DONE IN (B)(6) 2023, THE PATIENT EXPERIENCED THE FOLLOWING COMPLICATIONS: SEVERE ABDOMINAL PAIN AND PAIN IN THE ILIAC FOSSAE, DIFFICULTY WALKING, SERIOUS DIGESTIVE PROBLEMS WHEN INGESTING LIQUIDS AND SUDDEN ¿STABBING¿ PAINS IN THE ABDOMEN DURING THE DAY/NIGHT, SEVERE PULLING SENSATIONS IN THE TRANSVERSE ABDOMINAL MUSCLES.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Pain

  MAUDE report 23854819 ↗
• InjuryJul 21, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN ABOUT FIVE FIRINGS WERE PERFORMED TO PLACE MESH, IT PEELED OFF AND FURTHER TACKING (S) WAS PERFORMED AND THE PROCEDURE WAS COMPLETED, BUT THE MESH PEELED OFF A FEW DAYS LATER. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. AN OPEN PROCEDURE WAS DONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Blood Loss; No Code Available; Prolapse

  MAUDE report 8810102 ↗