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	12/03/2024
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 procedure on (b)(6) 2024, the physician reported that they were dissatisfied with the seal quality of the device.Physician reported that they received a complete tone faster than usual and when inspecting the seal could see that the seal was not adequate.A second device was opened to complete the procedure.Physician reported that he observed bleeding from the inadequate seal that had to be held closed by a grasper until a second device was opened.The procedure was a duodenal switch.No additional patient injury or intervention was reported.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, and there were no signs of physical damage.Functional testing was conducted, but the disposable was not detected by the generator.After further analysis, it was confirmed that the unit was incorrectly identified and shipped.For this reason, it was decontaminated by ebeam rays, which damaged its pc board.However, a new power cord was assembled to the handpiece in order to further investigate the returned unit.After that, the disposable was properly identified, and it could seal and cut the tissue.Additionally, jaw gap, force, and splay tests were conducted, and they were within expected parameters.Hence, the complaint cannot be confirmed.This observation will be monitored and trended.

• Brand Name: COOLSEAL¿ TRINITY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21035510
• Report Number: 3010377594-2024-00021
• Device Sequence Number: 8520546
• Product Code: GEI
• UDI-Device Identifier: 00850346007061
• UDI-Public: (01)00850346007061(17)260411(11)240411(10)24D11RH
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/22/2025

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
• Device Expiration Date: 04/11/2026
• Device Model Number: CSL-TR105-44
• Device Catalogue Number: CSL-TR105-44
• Device Lot Number: 24D11RH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Patient Sex: Unknown