MAUDE Adverse Event Report: Microline Surgical ReNew Handpiece, 34cm, Reusable; Manual, Detachable Surgical Instruments

Model Number	3904
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microline surgical is awaiting return of the device so that an investigation can be performed.
Event or Problem Description
During the procedure, about 30 minutes after start, a spark occurred at the joint between the handpiece and the scissors, causing damage to tissue outside the treatment area.The tissue that was unintentionally damaged was a blood vessel; hemostasis was achieved using an alternative device, and the procedure was completed successfully.No significant prolongation of the surgical duration or other issues related to the hemostasis were observed.The patient is doing well.

• Brand Name: ReNew Handpiece, 34cm, Reusable
• Common Device Name: Manual, Detachable Surgical Instruments
• Manufacturer (Section D): Microline Surgical; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): Microline Surgical; 50 dunham rd; suite 1500; beverly MA
• Manufacturer Contact: scott marchand-davis ; 50 dunham rd; suite 1500; beverly, MA
• MDR Report Key: 24803151
• Report Number: 1223422-2026-00005
• Device Sequence Number: 13247949
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2026

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: 3904
• Device Catalogue Number: 3904
• Device Lot Number: 00168083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 04/06/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 07/09/2026; 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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