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

Model Number	G2200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the system powered up with error code 480 (sensor interface error) indicating remove delivery device but no delivery device was plugged in.Turned the generator off and on but the issue was not resolved.Procedure was canceled.Patient outcome information was not provided.
Event or Problem Description
It was reported that the system powered up with error code 480 (sensor interface error) indicating remove delivery device but no delivery device was plugged in.Turned the generator off and on but the issue was not resolved.Procedure was canceled.No complications to the patient occurred due to this event.
Event or Problem Description
It was reported that the system powered up with error code 480 (sensor interface error) indicating remove delivery device but no delivery device was plugged in.Turned the generator off and on but the issue was not resolved.Procedure was canceled.No complications to the patient occurred due to this event.
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.Based on the information available, the device was not returned and there is no sufficient information to determine the cause contributing to the reported issue.An evaluation conclusion code of no problem detected was assigned to this investigation.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS; 925 enterprise avenue; milaca MN 56353
• MDR Report Key: 9496664
• Report Number: 2937094-2019-61692
• Device Sequence Number: 2079308
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 03/11/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 03/05/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 12/20/2019; 03/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other