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

Model Number	CSL-TR105-37
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
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.H3: 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 and a definitive root cause for the reported event could not be determined.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) 2023, the tip of the device broke off in patient.It was reported that the physician was able to remove the pieces from the patient and used a second device to complete the procedure.No patient injury reported.

• Brand Name: COOLSEAL¿ TRINITY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 s. 104th street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 s. 104th street; suite 200; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 17092027
• Report Number: 3010377594-2023-00012
• Device Sequence Number: 6070630
• Product Code: GEI
• UDI-Device Identifier: 00850346007047
• UDI-Public: (01)00850346007047(17)241123(11)221124(10)22L24RC
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203183
• 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): 06/26/2023

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 Expiration Date: 11/23/2024
• Device Model Number: CSL-TR105-37
• Device Catalogue Number: CSL-TR105-37
• Device Lot Number: 22L24RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown