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

Model Number	20-1082KI
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Upper Respiratory Tract Injury (4599)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are attempting to have the device returned.The investigation is ongoing, and we are continuing to try to get more information about the incident.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges that a patient was burned with our bipolar unit during an open neck procedure.The patient's trachea was burned.
Event or Problem Description
Complainant alleges that a patient was burned with our bipolar unit during an open neck procedure.The patient's trachea was burned, creating a hole in the trachea.The patient was left intubated in the icu overnight.".
Additional Manufacturer Narrative
The actual device was returned for evaluation.The device was evaluated, and many tests were performed including dimensional tests, hipot, and continuity tests, with no discrepancies found in relation to the established specifications.The dhr was checked, and no anomalies were found.The work instructions and drawings were reviewed, and no anomalies were found.This complaint could not be confirmed, and no root cause was able to be identified.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 KIT
• 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: 22056377
• Report Number: 3007208013-2025-00017
• Device Sequence Number: 17931285
• Product Code: GEI
• UDI-Device Identifier: 00841785103001
• UDI-Public: 00841785103001
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 20-1082KI
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown