MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; BABCOCK FORCEPS INSERT Ø 10MM

Model Number	8395214
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Richard wolf (rwgmbh) has concluded its investigation.There were no indications of a material or manufacturing defect.It is suspected that mechanical overload was the cause of the reported event.The type 8395214 inner forceps components have been in the product range since october 1993.Since then, there have been no further complaints regarding this type of device.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, the joint hinge of one arm of the babcock forceps broke off.It fell into the surgical site and could not be retrieved even with the aid of a c-arm machine.The surgery was extended by approximately an hour.

• Brand Name: ERAGON MODULAR
• Common Device Name: BABCOCK FORCEPS INSERT Ø 10MM
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22798076
• Report Number: 9611102-2025-00042
• Device Sequence Number: 18270651
• Product Code: GEN
• UDI-Device Identifier: 04055207016756
• UDI-Public: 04055207016756
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 8395214
• Device Catalogue Number: 8395.214
• Device Lot Number: 1404043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2018
• 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