Symbotex SYM15FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521190405), received between Dec 13, 2017 and Sep 29, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 50938585 ↗
• InjuryMay 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE MESH WAS IMPLANTED ON (B)(6) 2023 AND ON (B)(6) 2025 THE PATIENT HAD EXPLORATORY LAPAROTOMY WHERE THE SURGEON OBSERVED THAT THE ANTI-ADHESIVE MEMBRANE OF THE MESH HAD COME INTO CONTACT WITH THE INTESTINE, RESULTING IN THE FORMATION OF A GEL-LIKE SUBSTANCE.

  Patient problems: Laceration(s)

  MAUDE report 22081630 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY PERIUMBILICAL EVENTRATION, ON THE NEXT DAY, THE PATIENT TAKEN BACK AS AN EMERGENCY ON (B)(6) 2024 FOLLOWING AN INFECTION OF THE PLATE, A NEW EVENTRATION CURE WITH REMOVAL OF THE PREVIOUSLY PLACED PLATE. A REQUEST FOR BACTERIOLOGY WAS MADE ON THE REMOVED PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 20799413 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 56 POST-OPERATIVE DAYS OF A LAPAROSCOPIC VENTRAL UMBILICAL HERNIA PROCEDURE, WHERE THE MESH AND TACKER WERE USED, ADDITIONAL SURGERY WAS PERFORMED TO PUMP OUT 1.5 LITERS OF LIQUID FROM THE ABDOMINAL CAVITY. IT WAS NOTED THAT THE TACKS WERE STILL FIXED IN THE PATIENT. IT WAS REPORTED THAT, THE PATIENT, AFTER BEING BETTER AFTER THE REINTERVENTION FOR EVACUATION OF A 5 LITER OF LIQUID, SAW THE PELVIC PAIN REAPPEAR AND THE CURRENT CONTROL CT SCAN CONFIRMED THE RECURRENCE OF THE INTRAPERITONEAL EFFUSION. THE BACTERIOLOGICAL SAMPLES REMAINED STERILE.

  Patient problems: Abdominal Pain; Pain; Seroma

  MAUDE report 12868689 ↗
• InjuryFeb 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, 23 DAYS POST-OPERATIVELY OF A LAPAROSCOPIC ABDOMINAL WALL HERNIA REPAIR, THE MESH HAD NOT FUSED WITH PERITONEUM. A PART OF TACKING CAME OFF AND WAS FOUND HANGING IN THE ABDOMINAL CAVITY. ON THE RIGHT SIDE, THE MESH WAS FOUND TO HAVE A GAP BETWEEN THE MESH AND PERITONEUM. THE THREAD FOR THE PLICATED HERNIA ORIFICE WAS ALSO IN THE CONDITION THAT HAD COME OFF. REPAIR FOR THE RELAPSE WAS DONE. A SMALL LAPAROTOMY WITH ANOTHER MESH WAS PERFORMED TO REPAIR THE RELAPSE.

  Patient problems: No Code Available

  MAUDE report 9708292 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED SMALL BOWEL OBSTRUCTION 7 DAYS FOLLOWING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR. POST OPERATIVE LAPAROTOMY WAS DONE TO RESOLVE THE ISSUE. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Injury; No Code Available; Obstruction/Occlusion

  MAUDE report 9563534 ↗
• MalfunctionAug 9, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN SPREADING THE MESH DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH, THE MESH BROKE WHEN PLACED IN THE ABDOMINAL WALL AND THERE WAS AN UNANTICIPATED TISSUE LOSS. A NEW MESH WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768809 ↗
• MalfunctionDec 13, 2017Degraded; Product Quality Problem; Degraded; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR PROCEDURE, WHILE THE MESH WAS BEING ATTACHED TO THE HERNIA DEFECT, THE DEVICE¿S MESH WAS DAMAGED, WHEREIN COLLAGEN FILM PEELED OFF IN THE MIDDLE OF THE MESH IN ONE AREA AND THE COLLAGEN WAS FLAKING AROUND THE OUTSIDE. SALINE WAS USED TO HYDRATE THE MESH. ANOTHER PIECE OF MESH WAS OPENED AND USED IN ORDER TO RESOLVE THE ISSUE. A 10/12 TROCAR WAS USED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7112345 ↗