Symbotex SYM1510FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521190382), received between Mar 30, 2018 and Oct 16, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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.

• MalfunctionOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THERE WAS A MESH REACTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465247 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS FOLLOWING LAPAROSCOPIC IPOM (INTRAPERITONEAL ONLAY MESH REPAIR) UMBILICAL HERNIA PROCEDURE WHEREIN THE MESH WAS FIXATED WITH SUTURE, THE MESH HAD TO BE EXPLANTED THROUGH MESH EXPLANTATION PROCEDURE DUE TO A PARALYTIC ILEUS AND SEVERE INCREASE IN SIGNS OF INFECTION. IT WAS NOTED THAT AFTER THE SURGEON TIP IN THE UMBILICUS TO REPOSE THE HERNIA SACK, THE SURGEON GRABBED THE MESH WITHOUT CHANGING THE SURGICAL GLOVES.

  Patient problems: Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18862586 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR UMBILICAL HERNIA, THE MESH WAS PLACE ALIGNED LONGITUDINALLY IN THE MIDDLE AND WAS INTRODUCED LAPAROSCOPICALLY THROUGH TROCAR. THE MESH WAS SECURED BY TRANSFACIAL SUTURES AND TACKS. THE SURGEON HAS NOT CHANGED THE GLOVES AND TIP IN THE UMBILICUS TO REPOSE THE HERNIA SACK, THEN GRAB THE MESH. THE MESH WAS NOT HYDRATED NOR CUT PRIOR IMPLANTATION. THE PATIENT WAS DISCHARGED ON THE FIRST DAY WITHOUT IMMEDIATE UNUSUAL SYMPTOMS. THEN ON THE 8TH DAY, THERE WAS A REDNESS OF THE NAVEL, DIFFUSE ABDOMINAL PAIN AND SIGNS OF INFECTION INCREASED. 30 DAYS AFTER, THE MESH WAS EXPLANTED DUE TO INFLAMMATION. CURRENTLY, THE SMALL WOUND HEALING DISORDER NEAR THE NAVEL HEALED COMPLETELY. THERE WAS NO PLAN FOR REPLACEMENT OF THE MESH.

  Patient problems: Abdominal Pain; Inflammation; Unspecified Infection

  MAUDE report 18862491 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE FROM LAPAROSCOPIC ESOPHAGEAL HERNIA SURGERY THROUGH LAPAROSCOPIC NISSEN FUNDOPLICATION, PATIENT HAD TISSUE DAMAGE - FISTULOUS HOLE ON DISTAL ESOPHAGUS AND THE ENTEROCUTANEOUS FISTULA. THE PATIENT HAD TO BE RE-HOSPITALIZED. AN ENDOSCOPY AND FISTULA TREATMENT HAD TO BE PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Fistula; No Code Available; Tissue Damage

  MAUDE report 9788229 ↗
• MalfunctionMar 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA PROCEDURE, THE FIXATION SUTURE WAS TORN WHILE PULLING UP THE MESH TO THE PATIENT'S ABDOMINAL WALL. ANOTHER MESH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428129 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING SEEMINGLY SUCCESSFUL LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH THIS MESH, THE PATIENT REPORTED TO HAVE SIGNIFICANT DISCOMFORT AT THE REPAIR SITE. DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND IDENTIFIED SEVERE ADHESIONS INVOLVING BOWEL STUCK TO THE MESH. ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE. ADHESIONS WERE SUCCESSFULLY REMOVED, MESH WAS LEFT IN PLACE (IT HAD REMAINED EXACTLY AS POSITIONED IN INITIAL REPAIR) AND AN ANTI-ADHESIVE PRODUCT WAS APPLIED TO PREVENT FURTHER ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; No Code Available

  MAUDE report 8397195 ↗
• MalfunctionMar 30, 2018Torn Material; Torn Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, DURING INSERTION INTO PATIENT AND USING THE ABSORBATACK TO FIXATE MESH ONTO THE ABDOMINAL WALL, A HOLE WAS SHOT IN THE MESH, RESULTING IN A TACK IN THE ABDOMINAL WALL BUT NO FIXATION FOR THE MESH. THE TACK FROM THE ABSORBATACK SHOT A HOLE IN THE MESH. THE DEVICE REMAINS IMPLANTED. NO INJURY TO THE PATIENT. TACKS WERE FIRED NORMALLY FROM THE DEVICE. THE SURGEON MANAGED TO FIXATE THE MESH AFTER THE ISSUE OCCURRED. THE SURGEON SUCCEEDED IN FIXATING THE MESH WITH THE ABSORBATACK WITHOUT MAKING ANY MORE HOLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385477 ↗