ERAGON MODULAR 8394258Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207056059), received between May 20, 2021 and May 20, 2021 — classified as 1 malfunction.

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

• MalfunctionMay 20, 2021Material Separation; Material Separation

  RW MIC RECEIVED A RESPONSE FROM THE USER FACILITY WITH ADDITIONAL INFORMATION: PROCEDURE: ROBOTIC LOW ANTERIOR RESECTION AND CREATION OF DIVERTING LOOP ILEOSTOMY, FLEXIBLE SIGMOIDOSCOPY. DEVICE FAILURE HAPPENED WHILE THE INSTRUMENT WAS BEING USED INTRAOPERATIVELY. THIS WAS AFTER THE PATIENT WAS ASLEEP AND INSUFFLATION WAS COMPLETE. THIS WAS A ROBOTIC CASE SO WE WERE USING TROCHARS, SCOPE, ELECTROCAUTERY GENERATOR AND CAMERA. THE DEVICE WAS RETURNED TO RICHARD WOLF AND A VISUAL INSPECTION WAS COMPLETED. THE INVESTIGATION FOUND THAT ONE SIDE OF THE FORK, WHICH ENCLOSES THE HINGES, IS BROKEN OFF AND IS NOT PRESENT. ALSO MISSING ARE AT LEAST TWO CONNECTING PINS AND TWO GUIDE PINS. IT SEEMS THAT A LOT OF LATERAL FORCE WAS APPLIED TO THE JAWS, WHICH CAUSED THE FORK TO BREAK. THESE ARE RELATIVELY LONG JAWS, AND THIS LEVERAGE CAN CREATE A LOT OF INTERNAL STRAIN. CARE MUST BE TAKEN NOT TO OVERLOAD THE DELICATE COMPONENTS. THE ROOT CAUSE WAS ATTRIBUTED TO HUMAN ERROR. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855436 ↗