MAUDE Adverse Event Report: POLLOGEN LTD LEGEND PRO; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES, PRODUCT CODE:GEI

Model Number	LEGEND PRO
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burns following treatment by legend pro device.Described heat as being hotter than a sunburn and was in pain.Advised client to put ice.Patient was very pink and swollen and showed signs of a severe histamine response and possible allergic reaction.The customer spoke to the patient every day during week monday - friday.On friday it was still swollen and was experiencing itchiness and pain.

• Brand Name: LEGEND PRO
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES, PRODUCT CODE:GEI
• Manufacturer (Section D): POLLOGEN LTD; 6 kaufman st.; tel aviv, israel 68012 98; IS 6801298
• MDR Report Key: 11702056
• Report Number: 1720381-2021-00002
• Device Sequence Number: 17019152
• Product Code: GEI
• UDI-Device Identifier: 07290016586138
• UDI-Public: 07290016586138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021
• Report Date (Section F): 04/21/2021

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: Other
• Device Model Number: LEGEND PRO
• Device Catalogue Number: 30020000U
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2021
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 04/21/2021