MAUDE Adverse Event Report: ASPEN SURGICAL PRODUTS, INC. SYNOVIS BIPOLAR FORCEPS, MIDAS TOUCH

Model Number	GEM4025J-NS-S
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "i received a call with our customer stating that all 14 gem bi-polars recently purchased are not cauterizing, sparking and will not work correctly.".
Additional Manufacturer Narrative
The device was returned for evaluation.It was subjected to functional testing (hipot and continuity) using a voltage of 500 v, in accordance with ifu 0001331, with no anomalies detected.The complaint could not be confirmed.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: SYNOVIS BIPOLAR FORCEPS, MIDAS TOUCH
• Common Device Name: BIPOLAR FORCEPS
• Manufacturer (Section D): ASPEN SURGICAL PRODUTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 24012697
• Report Number: 3002750084-2026-00003
• Device Sequence Number: 9215322
• Product Code: LRW
• UDI-Device Identifier: 00844735006049
• UDI-Public: 00844735006049
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: GEM4025J-NS-S
• Device Lot Number: 485329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/12/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown