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

Model Number	CSL-MN103-20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
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.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 mini procedure on (b)(6) 2024, the physician reported that a small piece broke off the device mid procedure.Graspers were used to remove the piece since it fell into the patient.The procedure was completed using a second device.No patient injury reported.No other information is available.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted and the links were disconnected and a piece of metal was sent separately in a container.Functional testing was not conducted due to the issue was be confirmed in the visual inspection and due to the damage in the device the testing cannot be performed.Hence, the complaint can be confirmed.This observation will be monitored and trended.

• Brand Name: COOLSEAL¿ MINI
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 20363603
• Report Number: 3010377594-2024-00015
• Device Sequence Number: 20564255
• Product Code: GEI
• UDI-Device Identifier: 00850346007085
• UDI-Public: (01)00850346007085(17)260115(11)240115(10)75LC1415
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202114
• 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): 02/18/2025

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: 01/15/2026
• Device Model Number: CSL-MN103-20
• Device Catalogue Number: CSL-MN103-20
• Device Lot Number: 75LC1415
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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
• Patient Sex: Unknown