MAUDE Adverse Event Report: JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL COOLSEAL REVEAL; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	CSL-RV105-10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Coolseal was being used by physician and thumb lever broke off, hit the physician in the head and fell on the floor.

• Brand Name: COOLSEAL REVEAL
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL; 331 south 104th street; suite 200; louisville CO 80027
• MDR Report Key: 19948936
• Report Number: 19948936
• Device Sequence Number: 7244458
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: (01)00850346007092(17)260417
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/16/2024
• Report Date (Section F): 07/16/2024

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
• Device Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• 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
• Date Report Sent to FDA: 07/16/2024