MAUDE Adverse Event Report: BOLDER SURGICAL COOLSEAL¿ TRINITY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CSL-TR105-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coolseal procedure on (b)(6) 2025, the physician was performing a gastric sleeve and when sealing fatty tissue around a vessel the physician clamped a large vessel.The seal button was pressed and the system gave a complete seal tone.And when the physician released the vessel significant bleeding occurred.Surgeon was able to seal using surgicel and sutures.The procedure was completed without any further issue.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H6: component code appropriate term/code not available: suggested code : electrosurgical cutter and coagulator.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted there were no signs of physical damage.Functional testing was conducted; the disposable could seal and cut as expected, seal integrity was reviewed under microscope, and it was in good shape.Jaws gap, force and splay tests were also conducted, and the unit was within the expected parameters.Hence, the complaint cannot be confirmed.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• Brand Name: COOLSEAL¿ TRINITY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 22726240
• Report Number: 3010377594-2025-00017
• Device Sequence Number: 15739095
• Product Code: GEI
• UDI-Device Identifier: 00850346007061
• UDI-Public: (01)00850346007061(17)261203(11)241203(10)24M03R
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211579
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CSL-TR105-44
• Device Catalogue Number: CSL-TR105-44
• Device Lot Number: 24M03R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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; Required Intervention
• Patient Sex: Unknown