ERAGON MODULAR 8393249Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207055731), received between Aug 28, 2018 and Aug 11, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Material Fragmentation

  It was reported that during laparoscopic surgery while moving bowel, a small metal piece of the grasper fell off. An X-Ray was taken and the missing piece was visualized. However, it was unable to be removed. The Port site extended, and the small piece of the grasper was located. The Bowel resection completed.

  Patient problems: Insufficient Information

  MAUDE report 50201456 ↗
• InjuryAug 11, 2026Material Fragmentation

  It was reported that during laparoscopic surgery, the grasper broke inside of patient while grasping a piece of bowel to hold and retract it. Two pieces were located and removed at that time. A third piece was determined to be missing and unable to be located.An X-Ray was taken and the Third piece was visualized. However, it was unable to be removed via the laparoscopic surgery. Therefore, the procedure was converted to an open resection, and the third piece was removed. The bowel resection was completed.

  Patient problems: Insufficient Information

  MAUDE report 50201451 ↗
• MalfunctionDec 27, 2022Material Fragmentation; Material Fragmentation

  RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN KNITTLINGEN /MANUFACTURER WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: ITEM 8393249 LOT 4500250452, INSTRUMENT WAS BEING USED FOR A LAPAROSCOPIC BOWEL CASE. ONCE THE CASE HAD FINISHED THE SCRUB NURSE REALIZED THAT AN INSTRUMENT WAS DAMAGED AND THAT A PIECE WAS MISSING. AFTER AN XRAY OF THE PATIENT THE MISSING PIECE WAS LOCATED IN THE PATIENT WHO WAS SUBSEQUENTLY RE-OPENED AND THE PIECE WAS REMOVED. PATIENT HAD TO RETURN TO THEATRE AND BE ANESTHETIZED FOR A 2ND TIME TO REMOVE BROKEN ITEM. RWGMBH MDR AWARENESS DATE: (B)(6) 2022

  Patient problems: Foreign Body In Patient

  MAUDE report 16055635 ↗
• MalfunctionSep 14, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  RWMIC EVALUATION 09/24/2020: FINDINGS, INSERT 8393.249: THE WELDING SEAMS AROUND ALL 4 RIVETS ARE CRACKED, BUT THE RIVETS ARE PRESENT. THE PULLROD CONNECTOR IS BROKEN JUST PROXIMAL OF THE SEGMENT CONNECTIONS, BUT ALL PARTS ARE PRESENT. SHEATH 8393.933 / 1341886: DISTAL END OF SHEATH IS DEFORMED AND BENT. THE CONDITION OF THESE 2 COMPONENTS OF THE MODULAR SYSTEM SHOWS EXTREME MIS-USE OF THE BOWEL GRASPER. THE JOINTS WERE OVERLOADED WITH GRASPING FORCE, AND THE WHOLE DISTAL SECTION OF THE INSTRUMENT HAS BEEN BENT. THE CONDITION REPORTED BY THE USER FACILITY IS CONFIRMED. PRODUCT DISPOSITION IS SCRAP. POSSIBLE ROOT CAUSE IS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10532328 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (HEREINAFTER REFERRED TO AS RWMIC) WAS MADE AWARE OF AN EVENT FROM RICHARD WOLF (B)(4) (HEREINAFTER REFERRED TO AS (B)(4)) ON 8/17/2018. (B)(4) WAS NOTIFIED ON 7/31/2018 BY DISTRIBUTOR IN (B)(6) OF AN EVENT THAT OCCURRED AT THE HOSPITAL ON (B)(6) 2018 DURING A SMALL BOWEL OCCLUSION SURGERY. DURING PROCEDURE 7 PERFORATIONS WERE NOTED AND DETERMINED TO BE LIKELY CAUSED BY MANIPULATION WITH THE FORCEPS. THE BOWEL WAS UNCHARACTERISTIC DURING THE PROCEDURE AND THE MANIPULATION WAS NOT EXCESSIVE. THE DOCTOR HAD TO SET SEVERAL CLAMPS WHICH HAD TO BE REMOVED LATER. THE PATIENT REQUIRED TO STAY IN HOSPITAL LONGER THAN EXPECTED.

  Patient problems: Bowel Perforation; Perforation

  MAUDE report 7824372 ↗