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

Model Number JR-SE20

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Device stopped working, stopped sealing tissue.Manufacturer response for electrosurgical, cutting coagulation accessories, just right sealer (per site reporter).

• Brand Name: JUSTRIGHT SEALER
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): JUSTRIGHT SURGICAL, LLC; 331 s. 104th street, suite 200; louisville CO 80027
• MDR Report Key: 11640694
• MDR Text Key: 244618733
• Report Number: 11640694
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00865163000126
• UDI-Public: (01)00865163000126
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JR-SE20
• Device Catalogue Number: JR-SE20
• Device Lot Number: 75K12106
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1