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

Model Number	CSL-TR105-37
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.A consistent reactivate / incomplete seal tone was confirmed.The root cause was found to be a mechanical failure of a broken jaw wire, resulting in an open circuit.The coolseal system appropriately delivered the incomplete seal tone under the open circuit condition.The report of inadequate seals following seal complete tones was not confirmed.The device was tested for all seal quality related characteristics and was within specifications.
Event or Problem Description
It was reported that the instrument was giving good sealing tones (seal complete tone), but there was bleeding observed from cutting surfaces.Following this the generator provided incomplete sealing alerts (reactivate / incomplete seal tone), the device was not sealing.Patient information is unavailable as it is not allowed to publish according to (b)(6) rules.

• 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: 14057195
• Report Number: 3010377594-2022-00007
• Device Sequence Number: 17390228
• Product Code: GEI
• UDI-Device Identifier: 10850346007044
• UDI-Public: 01108503460070441722072810
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 04/08/2022

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: 07/28/2022
• Device Model Number: CSL-TR105-37
• Device Catalogue Number: CSL-TR105-37
• Device Lot Number: 21070041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 04/08/2022
• 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 Sex: Unknown