MAUDE Adverse Event Report: JUSTRIGHT SURGICAL, LLC JUSTRIGHT SEALER; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	JR-SE20
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device stopped working, stopped sealing tissue.Manufacturer response for electrosurgical, cutting coagulation accessories, just right sealer (per site reporter).

• Brand Name: JUSTRIGHT SEALER
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): JUSTRIGHT SURGICAL, LLC; 331 s. 104th street, suite 200; louisville CO 80027
• MDR Report Key: 11640694
• Report Number: 11640694
• Device Sequence Number: 3100065
• Product Code: GEI
• UDI-Device Identifier: 00865163000126
• UDI-Public: (01)00865163000126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• Report Date (Section F): 03/22/2021

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: Other
• Device Model Number: JR-SE20
• Device Catalogue Number: JR-SE20
• Device Lot Number: 75K12106
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/22/2021