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

Model Number	CSL-TR105-37
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
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.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.
Event or Problem Description
It was reported that during a coolseal trinity on (b)(6) 2026, the physician reported that the device was not sealing sufficiently and caused bleeding from small vessels and were oozing more than normal.The exact amount of blood could not be quantified.The physician decided to swith to another modality of device and was able to complete the procedure.No patient injury was reported and no medical intervention was required at the end of procedure.Patient was discharged as normal protocol.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, and no damage was observed in the device.Functional testing was conducted and the device opened and closed, the knife worked as intended, and seal and cut as intended.Internal inspection was performed, and some wires were pulled out, and it was observed one wire damaged, this issue creates an intermittent short circuit which impacted the sealing performance.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 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
• MDR Report Key: 24688283
• Report Number: 3010377594-2026-00004
• Device Sequence Number: 9770545
• Product Code: GEI
• UDI-Device Identifier: 10850346007044
• UDI-Public: (01)10850346007044(17)270708(11)250708(10)25H08RB
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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): 05/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CSL-TR105-37
• Device Catalogue Number: CSL-TR105-37
• Device Lot Number: 25G08RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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