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

Model Number	CSL-TR105-30
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coolseal procedure on (b)(6) 2025, during the middle of the procedure while performing a laparoscopic diaphragmatic hernia on a 1 year old, the staff noticed a black material on the abdomen coming from the device.The coolseal was checked and it was noticed that the coating close to the tip was peeling.The device was exchanged for a new device and the procedure completed successfully.Material was observed inside the cavity and it was irrigated and flushed.No additional medical intervention was reported.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.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; the impact on the coating was focused on the clevis and distal tip of the shaft.In addition, there is evidence of scratches over the section in which the coating was not present.After reviewing the entire shaft and handpiece, it was identified that only the distal part of the shaft coating presented scratches and some small sections with damage that exposed the outer tube.Functional testing was not conducted since the customer has not reported functional issues.The complaint could be confirmed during the visual inspection.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; 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: 22692235
• Report Number: 3010377594-2025-00014
• Device Sequence Number: 18403321
• Product Code: GEI
• UDI-Device Identifier: 00850346007030
• UDI-Public: (01)00850346007030(17)261011(11)241011(10)24K11RN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: CSL-TR105-30
• Device Catalogue Number: CSL-TR105-30
• Device Lot Number: 24K11RN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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