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

Model Number	CSL-TR105-44
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coolseal trinity procedure on august 22nd, the physician reported that it was experiencing a ¨little bleeding issue¨, it was reported that he went back to seal three times and was unsuccessful.The procedure was a modified duodenal switch, physician reported that around 12 seals had to be resealed.The device was exchanged, and no injury was reported.No medical intervention was required.The procedure was completed successfully with a second device.The amount of bleeding was reported as not a high amount.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.1 nce was observed related to the disposition of finished goods.Rework was performed and the accepted units were released.The device was released meeting all qa specifications 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.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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 36 & 37 apple ridge road; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 36 & 37 apple ridge road; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 20262887
• Report Number: 3010377594-2024-00009
• Device Sequence Number: 8261042
• Product Code: GEI
• UDI-Device Identifier: 00850346007061
• UDI-Public: (01)00850346007061(17)250427(11)230428(10)23D28RB
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K211579
• 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
• Report Date (Section B): 09/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2025
• Device Model Number: CSL-TR105-44
• Device Catalogue Number: CSL-TR105-44
• Device Lot Number: 23D28RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown