MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. RENEW; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	3142
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Microline surgical endocut scissor tip was reported to be dull by doctor and reported to be making a clicking sound when operated by staff.When this was noticed a new scissor tip was given that worked fine.
Event or Problem Description
Microline surgical endocut scissor tip was reported to be dull by doctor and reported to be making a clicking sound when operated by staff.When this was noticed a new scissor tip was given that worked fine.

• Brand Name: RENEW
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 9156833
• Report Number: 9156833
• Device Sequence Number: 2019582
• Product Code: OTJ
• UDI-Device Identifier: 08719324463171
• UDI-Public: (01)08719324463171
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019
• Report Date (Section F): 09/06/2019

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: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 00147449
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/06/2019