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 generator screen became completely black.The patient was under anesthesia when the issue was noted.The procedure was not completed due to this event.No injury to the patient occurred due to this event.Patient current condition is good.
Additional Manufacturer Narrative
The product was not returned so no physical analysis could be performed.A review of the device history record confirmed that the device met all material, assembly and performance specifications prior to release.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential causes and controls for complaints related to the clinical event were identified.Based on the information available, an evaluation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the generator screen became completely black.The patient was under anesthesia when the issue was noted.The procedure was not completed due to this event.No injury to the patient occurred due to this event.Patient current condition is good.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• MDR Report Key: 9492517
• Report Number: 2937094-2019-61688
• Device Sequence Number: 16447890
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2020

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?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other