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

Model Number	8393184
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Peritonitis (2252)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.Richard wolf gmbh has asked richard wolf france to contact the user for more details.Richard wolf gmbh has requested an affected forceps for investigation.According to the user facility, it is a general problem with the forceps, they cannot provide any device for investigation.Rw gmbh considers this matter open.Rw gmbh tries to collect one device in question to be able to evaluate the reported issue.
Event or Problem Description
Richard wolf gmbh complaint reference (b)(4).User report mv-2002-00463 in france.The user has reported the following: gripping forceps too traumatic for the small intestine and digestive tract repeated wounds, requiring modification of the procedure, sutures etc.Clinical consequence: peritonitis, recovery, major risk.Rwgmbh awareness date, 22-aug-2022.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new information about this mdr.New information: b4, b5, d9, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), and h10.Richard wolf france was commissioned to obtain additional information or a sample part.The efforts were unsuccessful.When reviewing the complaint records at richard wolf gmbh, no comparable cases / matches were found.As no lot number was provided, no conclusions could be drawn with regard to the date of manufacture.In the corresponding risk analysis b1-2 rev.05, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to an unserviceable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.As no new risks have emerged from the investigation of the current complaint case, the risk assessment remains valid in view of the facts described.The user is informed in the related instructions for use ga-s027 / en / 2019-11 v10.0 / pk19-9850 in chapters 10 and 11 to check the instrument for possible damage before and after use.In addition, the user is informed that improper use may result in damage to the instrument: 10 use warning the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.- immediately before and after use, check the products for damage, loose parts and completeness.Make sure that no missing instrument parts remain in the patient.- do not use products which are damaged or incomplete or have loose parts.10.1 preparation 1.Check assembly: section 10.2 assembly 2.Perform a visual check: section 11.2 visual checks.10.5 general notes and instructions for use warning danger of injury.When inserting and retracting instruments with the jaw section open.Unintentional tissue damage, damage to the distal end of the trocar sleeve / endoscope, and to the jaw section is possible.Only insert and retract instruments with the jaw section closed and under visual control.11 checks warning injuries by damaged or incomplete products! injuries of the patient, user and others are possible.- do not use the products if they are damaged, incomplete or have loose parts.- run through the checks before and after each use.Based on the information available to us, no general product or design problem can be identified.From a manufacturing or design point of view, no systematic deficiencies could be identified at this point in time, so that no measures were deemed necessary.
Event or Problem Description
Richard wolf gmbh reference complaint (b)(4) (fu1 mdr / no information - device not returned).The purpose of this submission is to report that device evaluation is not available due to device not returned to manufacturer for investigation.

• Brand Name: ERAGON
• Common Device Name: GRASP. FORCEPS INSERT Ø 5MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehlrich ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15455463
• Report Number: 9611102-2022-00045
• Device Sequence Number: 15164110
• Product Code: GCJ
• UDI-Device Identifier: 04055207015810
• UDI-Public: 04055207015810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8393184
• Device Catalogue Number: 8393.184
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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