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

Model Number	CSL-TR105-37
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the device not sealing is component wear causing electrical continuity failure.Based on the reported number of seals preformed (100-300) and the observed component wear, the likely cause is usage of the device beyond the recommended maximum number of cycles (70).The root cause of the reported bleeding could not be definitively determined.
Event or Problem Description
It was reported that the trinity sealer stopped sealing after 100-300+ seals.After performing as expected for the first part of the surgery, the device was cleaned.After this it was reported that the device "would not coagulate but did cut".The patient then presented an arterial bleeder.Another device was used, and the surgery was completed without incident.After the procedure, a wire protrusion was observed.

• 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 9717
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027 9717
• Manufacturer Contact: brad greathouse ; 331 south 104 street; ste 200; louisville, CO 80027-9717 ; 9702270102
• MDR Report Key: 14124213
• Report Number: 3010377594-2022-00009
• Device Sequence Number: 4249657
• Product Code: GEI
• UDI-Device Identifier: 10850346007044
• UDI-Public: 01108503460070441722100510
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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: 10/05/2022
• Device Model Number: CSL-TR105-37
• Device Catalogue Number: CSL-TR105-37
• Device Lot Number: 21100006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female