MAUDE Adverse Event Report: NORTECH SYSTEMS REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	G2200
Medical Device Problem Codes	No Display/Image (1183); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of convective radiofrequency water vapor thermal therapy, the generator booted ok, got to prime and then generator screen started flashing.There was no image.The procedure was not completed due to this event.The patient condition was reported to be good.No further information was provided.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS; 925 enterprise avenue; milaca MN 56353
• MDR Report Key: 10770857
• Report Number: 2937094-2020-00946
• Device Sequence Number: 16619986
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000003681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1