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

Model Number	CSL-TR105-37
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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 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.2 devices used in this procedure reported under : 3010377594-2023-00001.
Event or Problem Description
It was reported that on (b)(6) 2023 , during a cool seal trinity procedure , tiny pieces from the jaws broke off and were found in the belly of the patient.Pieces were removed and the patient was stable.No injury reported to the patient.No other information is available.Another device was used to complete the procedure.
Additional Manufacturer Narrative
The device was returned and visual inspection was conducted and the knife was damaged, even a part of it protruded from the outer tube and cut one of the wires.Functional testing was not conducted, because the issue mentioned with the knife prevents the normal function of the jaws, they were not able to be closed or opened.Hence, the complaint can be confirmed.This observation will be monitored and trended.

• Brand Name: COOLSEAL¿ TRINITY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 16286077
• Report Number: 3010377594-2023-00002
• Device Sequence Number: 14672799
• Product Code: GEI
• UDI-Device Identifier: 00850346007047
• UDI-Public: (01)00850346007047(10)22080012(11)220808(17)240808
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2024
• Device Model Number: CSL-TR105-37
• Device Catalogue Number: CSL-TR105-37
• Device Lot Number: 22080012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOLSEAL¿ TRINITY
• Patient Sex: Unknown