ProdiGI ERD-TWSGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521808386), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PRIMARY GRASPER WITH WIRE WAS DETACHED FROM THE TISSUE. THE PHYSICIAN SUCCESSFULLY USED A SECONDARY GRASPER TO PLACE THE WIRE BACK ONTO THE TISSUE. THE TRACTION WAS NOT AS DESIRED; THEREFORE, THE PHYSICIAN USED A SECOND SECONDARY GRASPER TO MAKE A TRIPOD SHAPE WITH WIRE. TRACTION WAS THEN GOOD. AT THE END OF THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE GRASPING FORCEPS TO REMOVE THE SECONDARY GRASPERS FROM THE HEALTHY TISSUE. AFTER TWO ATTEMPTS WHERE THE FORCEPS SLIPPED OFF GRASPER BODY, THE PHYSICIAN DETERMINED THAT THEY WOULD PREFER TO JUST LEAVE THE GRASPERS BEHIND RATHER THAN CONTINUE TRYING TO REMOVE IT. TECHNICAL SUPPORT EXPLAINED TO THE PHYSICIAN THAT THE IFU (INSTRUCTION FOR USE) RECOMMENDED TO REMOVE ALL COMPONENTS. FUJI CLUTCH CUTTERS WERE USED TO CUT THE TRACTION WIRE. THE WIRE AND GRASPERS ON THE LESION WERE REMOVED WITHOUT AN ISSUE. THE TWO SECONDARY GRASPERS THAT WERE ATTACHED TO THE HEALTHY TISSUE WERE LEFT IN PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO REPORTED ISSUES. IT WAS A 3 HOUR COMPLEX CASE. THE PHYSICIAN PLACED WIRE AND PRIMARY GRASPER PER STANDARD PROCEDURES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10587301 ↗