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	Serious Injury
Event or Problem Description
It was reported that on an unknown date a patient received a thyroidectomy and was released to same day without any symptoms.The surgery was reported as unremarkable.The device used in the procedure was discarded.The patient had to come back to the emergency room between 1 to 3 days post operation and required a surgical reintervention due to the presence of bleeding and hematoma.No other information is available.
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; san jose 20102
• MDR Report Key: 17461390
• Report Number: 3010377594-2023-00016
• Device Sequence Number: 2584489
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: 00850346007092
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/31/2023

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 Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown