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

Model Number	CSL-RV105-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Death
Event or Problem Description
It was reported that on an unknown date (within the last few months) a patient required a thyroid surgery involving a coolseal reveal, and it is unknown if the patient had any complications during the procedure but the tech confirmed that the patient was sent home post procedure.Then then patient returned to the er and waited 3 hours to be readmitted (causes are unknown) the patient was reported as¨ bleeding too much¨ and the patient later died.The cause of the death is unknown and it is unknown what were the symptoms that required the patient to come back to the er.The date of the death is unknown.
Additional Manufacturer Narrative
D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.

• 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 zone building b24; san jose 20102
• MDR Report Key: 17372375
• Report Number: 3010377594-2023-00015
• Device Sequence Number: 17109604
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: (01)00850346007092(17)250105(11)230105(10)23010016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/25/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2025
• Device Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Device Lot Number: 23010016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown