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

Model Number	3941
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite requests from microline surgical, the associated product was not returned to msi for investigation within 30+ days.This complaint will be closed per pmf-q3-003.If the item is returned, the complaint record will be reopened and investigated.
Event or Problem Description
While operating in the abdominal cavity a burn on ovarian tissue was noticed by surgeons.They stated they had the disp.Scissor tip on the microline pistol handle in view at all times and didn't see it touch the tissue that appear to have the scorch mark on it.Instrument was marked and labeled as broken; placed back in the tray for processing.Processing center indicates that this was processed per procedure and passed all quality test of laparoscopic equipment.

• Brand Name: RENEW XR HANDPIECE, 34CM, REUSABLE
• Common Device Name: LAPAROSCOPIC, 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: 21179271
• Report Number: 1223422-2024-00043
• Device Sequence Number: 15604057
• Product Code: GEI
• UDI-Device Identifier: 00811099013761
• UDI-Public: 00811099013761
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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: 3941
• Device Catalogue Number: 3941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 01/17/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White