MAUDE Adverse Event Report: Richard Wolf GmbH ERAGON MODULAR; INTESTINE GRASP. FORCEPS INSERT Ø 5MM

Model Number	8393249
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: ERAGON MODULAR
• Common Device Name: INTESTINE GRASP. FORCEPS INSERT Ø 5MM
• Manufacturer (Section D): Richard Wolf GmbH; pforzheimer straße 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): Richard Wolf GmbH; pforzheimer straße 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer straße 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 50201451
• Report Number: 9611102-2026-00048
• Device Sequence Number: 14823331
• Product Code: GCJ
• UDI-Device Identifier: 04055207055731
• UDI-Public: 04055207055731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8393249
• Device Catalogue Number: 8393249
• Device Lot Number: 4500383482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown