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

Model Number CSL-RV105-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/11/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6), an open right selective neck dissection was performed, and during the procedure, there was no incident or delay in the case.There were no potential adverse events and the procedure was completed without injury.Over the weekend the doctor received the patient with a hematoma.The patient had an additional surgery.No additional information available.

Manufacturer Narrative

Sa device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102 ; CR 20102
• MDR Report Key: 19213160
• MDR Text Key: 341388816
• Report Number: 3010377594-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: (01)00850346007092(17)250726(10)23G27RT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Device Lot Number: 23G27RT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female