ERAGON MODULAR 8393933Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207016312), received between Oct 18, 2018 and Mar 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Flaked; Flaked

  THE USER FACILITY REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS THAT ON (B)(6): DURING A GALL BLADDER PROCEDURE THIS MORNING, ONE OF THE GRASPERS THE SURGEON WAS USING, WHICH WAS THE BLUNT GRASPER, WHEN HE PUT IN THROUGH THE TROCAR THE COATING FROM THE SHEATH OF THE GRASPER FLAKED OFF INTO THE PATIENT'S CAVITY. HE STATED HE THOUGHT HE WAS ABLE TO SUCK OUT MOST OF IT AND IRRIGATED THE PATIENT'S ABDOMEN. HE IS NOT PLEASED WITH THE INSTRUMENTS AT THIS POINT. THIS OF COURSE IS A SAFETY ISSUE USING THE GRASPERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581324 ↗
• MalfunctionOct 18, 2018Use of Device Problem; Misassembly During Maintenance/Repair; Use of Device Problem; Misassembly During Maintenance/Repair

  FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION.

  Patient problems: Burn(s)

  MAUDE report 7982479 ↗
• MalfunctionOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON SEPTEMBER 18 2018, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): "TIP OF INSERT BROKE OFF IN PATIENT." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN. RWMIC RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE REPORTED MALFUNCTION COULD NOT BE VERIFIED DURING EVALUATION. DEVICE WAS FOUND TO HAVE NO PROBLEM. NO MANUFACTURING DEFECT WAS IDENTIFIED DURING THE EVALUATION. THE OTHER COMPONENTS OF THE MODULAR SYSTEM, THE GRASPING FORCEP INSERT AND THE PISTOL SHAPED HANDLE, ARE CONSIDERED SUSPECT DEVICES AND A REPORT WILL BE SUBMITTED FOR EACH DEVICE. GRASPING FORCEP INSERT - PRODUCT NUMBER 8393.292 (MDR 1418479-2018-00032). PISTOL SHAPED HA

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 7982472 ↗