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

Model Number	CSL-RV105-10
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/08/2024
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.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.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 reveal procedure on (b)(6) 2024, the surgeon reported that they could not seal small vessels during a thyroidectomy.Surgeon reported that there was an uncontrolled bleeding from small vessels which was easily managed but problematic, they had to use a harmonic to control the bleeding.Patient was doing fine.No other complications were reported.No other information available.
Additional Manufacturer Narrative
The device was returned and visual inspection was conducted, a tiny piece of tissue was found within the knife hole.Knife could be actuated and retracted without any additional force (the knife was not protruding nor creating any sort of short/open circuit).Functional testing was conducted and the disposable could seal and cut as intended, the splay measurement was performed and it was inside the expected parameters.The device met the manufacturer´s specifications thus the complaint could not be confirmed.This observation will be monitored and trended.

• Brand Name: COOLSEAL¿ REVEAL
• 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 park zone b24; san jose 20102
• MDR Report Key: 19793111
• Report Number: 3010377594-2024-00004
• Device Sequence Number: 4133885
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: (01)00850346007092(17)250726(11)230727(10)23G27RT
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K203640
• 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): 09/09/2024

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 Expiration Date: 07/25/2026
• Device Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Device Lot Number: 23G27RT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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