MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW XR HANDPIECE, 34CM (REUSABLE); REUSABLE HANDPIECE

Model Number	3941
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the affected device back so an investigation can be completed.Once the results of the investigation are available, a final adverse event report will be submitted.
Event or Problem Description
During a thl procedure dr.Santamaria flores and or staff noticed that the microline handpiece and scissor tip began sparking at the end of the case during monopolar cauterization.Settings were reported as "35 cut blend, coag 35." the instrument was removed from the patient, and the distal end appeared melted and charred.The instrument was put aside, and the manufacturer was contacted.No burns or injury to patient were reported at time of filing this air report.
Event or Problem Description
During a thl procedure dr.(b)(6) and or staff noticed that the microline handpiece and scissor tip began sparking at the end of the case during monopolar cauterization.Settings were reported as "35 cut blend, coag 35." the instrument was removed from the patient, and the distal end appeared melted and charred.The instrument was put aside, and the manufacturer was contacted.No burns or injury to patient were reported at time of filing this air report.
Additional Manufacturer Narrative
An investigation of the returned product was able to confirm the reported issue of electrical arcing.The renew handpiece was received, decontaminated, and visually inspected.Burn damage was seen on the overmolded hub of the tip and insulation tube of the handpiece.Although the exact cause of this incident cannot be determined, there are a few possibilities that point to why this event may have occurred.It is possible that the tip was not fully attached to the handpiece, allowing current to escape and cause an electrical arcing event.The shaft may have been in contact with another object that was not the intended site for energy delivery, so the current may have tracked along the surface of the shaft to the other object.The device may have been unintentionally damaged from handling and reprocessing, which compromised the insulation strength of the device.

• Brand Name: RENEW XR HANDPIECE, 34CM (REUSABLE)
• Common Device Name: REUSABLE HANDPIECE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 21413264
• Report Number: 1223422-2025-00003
• Device Sequence Number: 12841409
• Product Code: GEI
• UDI-Device Identifier: 00811099013761
• UDI-Public: 00811099013761
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K234147
• 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): 07/14/2025

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: 3941
• Device Catalogue Number: 3941
• Device Lot Number: 00175890
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown