MAUDE Adverse Event Report: Aspen Surgical Products, Inc. Symmetry Grasper, Hunter Bowel, Double-Action, Fenestrated, 5 mm diameter; Laparascopic Instrument

Model Number	97-1090RC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Symmetry Grasper, Hunter Bowel, Double-Action, Fenestrated, 5 mm diameter
• Common Device Name: Laparascopic Instrument
• Manufacturer (Section D): Aspen Surgical Products, Inc.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; +1(616)698-7100
• MDR Report Key: 50873757
• Report Number: 3002750084-2026-00106
• Device Sequence Number: 9314245
• Product Code: GCJ
• UDI-Device Identifier: 00887482132210
• UDI-Public: 00887482132210
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 97-1090RC
• Device Lot Number: 050223
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown