MAUDE Adverse Event Report: BOLDER SURGICAL CoolSeal¿ Mini; ELECTROSURGICAL, CUTTING & COAGULATION ACCESORIES

Model Number	CSL-MN103-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: CoolSeal¿ Mini
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; suite 200; louisvile CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CS 20102
• MDR Report Key: 50723321
• Report Number: 3010377594-2026-00013
• Device Sequence Number: 16044274
• Product Code: GEI
• UDI-Device Identifier: 00850346007085
• UDI-Public: 00850346007085
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: CSL-MN103-20
• Device Catalogue Number: CSL-MN103-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown