MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW XR HANDPIECE, 34CM; ENDOSCOPIC ELECTROSURGICAL HANDPIECE, ELECTRODE/MONOPOLAR/REUSABLE

Model Number	3941
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) hospital in (b)(6) , ri experienced an eletrcial arcing incident while using the monopolar function of a microline xr handpiece, and a microline scissor tip.The handpiece, and scissor tip have been retrieved and sent back to microline surgical headquarters for further investigation.Monopolar settings used inside of the patient were 60/40, and then 35/45.Staff atthe facility stated that the patient wasn't harmed, however the instrument did arc while inside the patient cavity.

• Brand Name: RENEW XR HANDPIECE, 34CM
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE, ELECTRODE/MONOPOLAR/REUSABLE
• 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: 19353023
• Report Number: 1223422-2024-00016
• Device Sequence Number: 7110188
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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
• Device Lot Number: 00171665
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/20/2024
• 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 Sex: Unknown