MAUDE Adverse Event Report: BOLDER SURGICAL COOLSEAL GENERATOR; GENERATOR FOR ELECTROSURGICAL TISSUE SEALER

Model Number	CSL-200-50
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/17/2000
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bolder surgical's italian distributor reported a patient leakage failure with coolsealtm generator serial number (b)(4) when performing testing per iec 60601-1.The coolsealtm generator was returned to bolder surgical for investigation and the complaint was confirmed.It was determined that an additional standoff was added to the base assembly during manufacturing, which led to a connection between the patient isolation barrier and ground.As a result, the 00165 device did not meet the iec 60601-1 patient leakage requirements for the device.This condition represents the potential to deliver unintended energy to a patient.Risk assessment has determined that patient injury is very unlikely.
Event or Problem Description
A distributor reported a patient leakage failure with coolseal generator.In this case there was no patient impact as the issue was discovered before the generator was put into service.

• Brand Name: COOLSEAL GENERATOR
• Common Device Name: GENERATOR FOR ELECTROSURGICAL TISSUE SEALER
• 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 ; 9792270102
• MDR Report Key: 13417863
• Report Number: 3010377594-2022-00003
• Device Sequence Number: 4761609
• Product Code: GEI
• UDI-Device Identifier: 00850346007023
• UDI-Public: 010085034600702311210714
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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 Model Number: CSL-200-50
• Device Catalogue Number: CSL-200-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown