MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. OLSEN BIPOLAR FORCEPS KIT, ADSON

Model Number	20-1082KI
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is in process of being returned.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "a patient was burned with our bipolar.".
Additional Manufacturer Narrative
The actual device was discarded, however a part from the same lot was returned to us for evaluation.That part passed all testing, including dimensional tests, hipot, and continuity tests, with no discrepancies found in related to the destablised specifications.The complaint could not be confirmed, and root cause could not be established.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: OLSEN BIPOLAR FORCEPS KIT, ADSON
• Common Device Name: BIPOLAR FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22196542
• Report Number: 3007208013-2025-00026
• Device Sequence Number: 8562697
• Product Code: GEI
• UDI-Device Identifier: 00841785103001
• UDI-Public: 00841785103001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: 20-1082KI
• Device Lot Number: 431928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Male