MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. CONMED CABLE, MONOPOLAR, VALLEYLAB TO 4MM LAP CONNECTION; MONOPOLAR CABLE

Model Number	60-5169-001
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not able to be returned for evaluation.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "60-5169-001: during a laparoscopic case, the conmed monopolar cord, which was connected to a laparoscopic hook and a valleylab force fx, started sparking, broke apart, and caught the surgical drape on fire, resulting in a hole the size of the quarter in the drape.No patient injury.".
Additional Manufacturer Narrative
The device was not available for return.In addition, despite repeated requests, we did not receive pictures or the lot number of the device.With so little information provided, the complaint could not be confirmed and root cause could not be established.If any additional relevant information is discovered, it will be submitted in a supplemental report.

• Brand Name: CONMED CABLE, MONOPOLAR, VALLEYLAB TO 4MM LAP CONNECTION
• Common Device Name: MONOPOLAR CABLE
• 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: 22060433
• Report Number: 3007208013-2025-00018
• Device Sequence Number: 8478199
• Product Code: GEI
• UDI-Device Identifier: 00841785113369
• UDI-Public: 00841785113369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111262
• 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): 06/10/2025

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: 60-5169-001
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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