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 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.

• 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: 50201456
• Report Number: 9611102-2026-00049
• Device Sequence Number: 5482365
• 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: 4500399935
• 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: 01/30/2024
• 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