MAUDE Adverse Event Report: BOLDER SURGICAL COOLSEAL¿ REVEAL; ELECTROSURGICAL, CUTTING & COAGULATION ACCESORIES

Model Number	CSL-RV105-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a physician that during an unknown procedure on an unknown date, while using a coolseal reveal, the physician had observed that fluid in the area of the jaws would get hot and around the area of incision, the physician observed some skin burns.It is unknown on how many patients, dates and procedures in which this has happened as the physician did not specify.The physician reported that electrolube was used to prevent from sticking.No reports of additional interventions or injuries.No other information available.
Additional Manufacturer Narrative
H6: component code: appropriate component term/code not available : suggested code: electrosurgical cutter.Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.
Additional Manufacturer Narrative
On february 26th 2026, on a follow up with the physician, additional information was received that the physician uses electrolube since many years ago.The physician reported that burns are not rare and not always with lube.Physician could not provide a number of events and reported that ¨it is what happens with energy devices and small incisions.No other information was received.

• Brand Name: COOLSEAL¿ REVEAL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; suite 200; louisvile CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; alajuela 20102
• MDR Report Key: 24442629
• Report Number: 3010377594-2026-00002
• Device Sequence Number: 10307764
• Product Code: GEI
• UDI-Device Identifier: 00850346007092
• UDI-Public: 00850346007092
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K203640
• 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): 03/05/2026

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 Model Number: CSL-RV105-10
• Device Catalogue Number: CSL-RV105-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown