Symbotex SYM2012EFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521190443), received between Sep 4, 2020 and Sep 4, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC TREATMENT OF AN UMBILICAL HERNIA WITH INTRAPERITONEAL MESH INLAY, THERE WERE PRONOUNCED ADHESIONS OF SMALL INTESTINE NOTED AT THE NET WITH CONSECUTIVE INTESTINAL OBSTRUCTION. THE PATIENT HAD TO UNDERGO AN EMERGENCY SURGERY, WHEREIN THE PROCEDURE STARTED LAPAROSCOPICALLY, AND WAS CONVERTED TO OPEN SURGERY DUE TO UNUSUAL EXTENT OF ADHESIONS.

  Patient problems: Adhesion(s); No Code Available; Obstruction/Occlusion

  MAUDE report 10494366 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THERE WERE PRONOUNCED ADHESIONS OF SMALL INTESTINE AT THE NET WITH CONSECUTIVE INTESTINAL OBSTRUCTION FOLLOWING A LAPAROSCOPIC TREATMENT OF AN UMBILICAL HERNIA WITH INTRAPERITONEAL MESH INLAY. THE PATIENT HAD TO UNDERGO AN EMERGENCY SURGERY, WHEREIN THE PROCEDURE STARTED LAPAROSCOPICALLY, AND WAS CONVERTED TO OPEN SURGERY DUE TO UNUSUAL EXTENT OF ADHESIONS.

  Patient problems: Adhesion(s); No Code Available; Obstruction/Occlusion

  MAUDE report 10494310 ↗
• InjurySep 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST LAPAROSCOPIC TREATMENT OF AN UMBILICAL HERNIA WITH INTRAPERITONEAL MESH INLAY, IT WAS NOTED THAT THERE WAS VERY PRONOUNCED ADHESIONS OF SMALL INTESTINE AT THE NET WITH CONSECUTIVE SMALL INTESTINE ILEUS (INTESTINAL OBSTRUCTION). THE PATIENT UNDERGONE EMERGENCY SURGERY. WHICH STARTED LAPAROSCOPICALLY BUT CONVERTED TO OPEN SURGERY DUE TO UNUSUAL EXTENT OF ADHESIONS.

  Patient problems: Adhesion(s); No Code Available; Obstruction/Occlusion

  MAUDE report 10494203 ↗
• InjurySep 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE LAPAROSCOPIC TREATMENT OF AN UMBILICAL HERNIA WITH INTRAPERITONEAL MESH INLAY, IT WAS NOTED THAT THERE WAS VERY PRONOUNCED ADHESIONS OF SMALL INTESTINE AT THE NET WITH CONSECUTIVE SMALL INTESTINE ILEUS (INTESTINAL OBSTRUCTION). PATIENT UNDERGONE EMERGENCY SURGERY WHICH STARTED AS LAPAROSCOPIC BUT CONVERTED TO OPEN SURGERY DUE TO UNUSUAL EXTENT OF ADHESIONS. INCIDENT HAD CAUSED PAIN TO PATIENT AND ADHESIOLYSIS WAS DONE TO RESOLVE THE ISSUE. EXTENDED INCISION WAS ALSO REPORTED.

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

  MAUDE report 10493024 ↗