MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; GRASP. FORCEPS INSERT Ø 5MM

Model Number	8393184
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report, the forceps have caused traumatic lesions, some of which with transmural perforation.Patient requiring surgical re-intervention due to small bowel perforations.The user did not specify whether a malfunction occurred while the forceps were being used or exactly what circumstances led to the patient's injury.
Additional Manufacturer Narrative
The customer sent in the grasp.Forceps insert ø 5mm along with the shaft tube and the handle pistol shaped mono for inspection.Upon inspection of the instruments by the technical department, no defect or fault was found.The grasp.Forceps insert ø 5mm in question fully complies with richard wolf gmbh's testing criteria and can be used without any issues.Over the past 5 years, there have been no complaints or incidents regarding grasp.Forceps insert ø 5mm, 8393184.Since the customer did not provide any further details about the incident and given that there have been no other complaints and that the inspected instrument showed no defects, we assume that this incident was caused by a handling error.In the instructions for use, ga-s027, chapters 9 checks and 10 use, provide sufficient guidance on visual and functional inspections.They also refer to the intended use and purpose of the product.At richard wolf gmbh risk analysis b1-211 for reusable, rigid, powered, non-optical forceps and scissors eragon iia / iib, version v00, manufacturing-, handling-, and design-related hazards regarding functional impairment, as well as risks arising from application errors were assessed in terms of the corresponding extent of damage and the assumed probability of occurrence and evaluated as an acceptable risk.Since the investigation of the current complaint case has not revealed any new risks, the risk assessment remains valid considering the facts described.A review of the facts reveals that, from both a manufacturing and a design perspective, there are no systematic defects.Based on the results described above (no defects or errors found), the cause of the customer's complaint cannot be clearly determined.No corrective actions are required based on the inspection results obtained.

• Brand Name: ERAGON MODULAR
• Common Device Name: 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25607356
• Report Number: 9611102-2026-00032
• Device Sequence Number: 5405870
• Product Code: GCJ
• UDI-Device Identifier: 04055207015810
• UDI-Public: 04055207015810
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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
• Operator of Device: Other
• Device Model Number: 8393184
• Device Catalogue Number: 8393.184
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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