ERAGON MODULAR 83930074Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207026625), received between Jul 8, 2020 and Dec 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2022Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; Difficult to Open or Close

  RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN (B)(4) (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: THE RESPECTIVE 5MM GRASPING FORCEPS WAS APPLICATED DURING A THORASCOPICAL RESECTION. AFTER GRASPING OF LUNGS TISSUE WITH ACTIVATED LOCK THE LOCK COULD NOT BE DEACTIVATED AGAIN. AS A CONSEQUENCE THE TISSUE IN THE JAWS HAD TO BE CUT OUT, SO THE FORCEPS COULD RECOVERED AGAIN. THE TREATMENT COULD BE COMPLETED WITHOUT ANY SIGNIFICANT DELAY. THE PATIENT'S CONSEQUENCE WAS DESCRIBED AS "GOOD". DUE TO THE PATIENT INJURY AND A POTENTIAL SERIOUS INCIDENT IF THE CASE WOULD REOCCUR, THE CASE IS DETERMINED AS REPORTABLE. THIS CASE WAS REPORTED BY THE USER TO THE GERMAN AUTHORITIES. RWGMBH MDR AWARENESS DATE: 10-OCT--2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005306 ↗
• MalfunctionJul 8, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED: THE HANDLES DO NOT OPEN/CLOSE RELIABLY (OCCURS REPEATEDLY)IN ONE PATIENT, THE HANDLE COULD NOT BE OPENED WHEN THE TISSUE WAS GRASPED ON THE JAW SIDE, SO THAT AN EMERGENCY THORACOSCOPY ALMOST BECAME NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10244774 ↗