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

Model Number	G2200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the during a convective radiofrequency water vapor thermal therapy procedure the screen had orange lines across and after 2 restarts it failed all together.The procedure was halfway completed when the generator issue occurred.The procedure was aborted with no harm to the patient.
Event or Problem Description
It was reported that the during a convective radiofrequency water vapor thermal therapy procedure the screen had orange lines across and after 2 restarts it failed all together.The procedure was halfway completed when the generator issue occurred.The procedure was aborted with no harm to the patient.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the issue was with the single board computer (sbc) board, it was replaced and the generator went through the burn-in process four more times and there were no issues.The generator was received with minor plastic enclosure damage.Most likely due to normal usage wear.Those parts were replaced.The rest of the generator was in overall good physical condition.Based on the issue with the sbc board, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEM INC; nw 7791; 1459; minneapolis MN 55485
• MDR Report Key: 9454562
• Report Number: 2937094-2019-61639
• Device Sequence Number: 19599811
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000003410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other