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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was present and had received a trus, including a modified prostate block with lidocaine in addition to lidocaine jelly in the urethra prior to water vapor therapy procedure.During the initial device set-up there was no indication that anything was wrong until performing the pretreatment cycle.Steam did not exit the tip of the device and error codes began to pop up regarding the rfcable port and replacing with a new device.After opening a second device and restarting the generator error code 4000 was prompted on the console.The error could not be bypassed and the procedure was aborted.There were no patient complications.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device confirmed the display of 4000 gui unable to communicate with master control unit (mcu).It was found that the mcu board had 2 loose connectors and insufficient solder flow on connectors j17 and j27; and the mcu board was replaced.The generator passed full functional and electrical safety testing.Based on the observed 4000 error, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient was present and had received a trus, including a modified prostate block with lidocaine in addition to lidocaine jelly in the urethra prior to water vapor therapy procedure.During the initial device set-up there was no indication that anything was wrong until performing the pretreatment cycle.Steam did not exit the tip of the device and error codes began to pop up regarding the rfcable port and replacing with a new device.After opening a second device and restarting the generator error code 4000 was prompted on the console.The error could not be bypassed and the procedure was aborted.There were no patient complications.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS; 925 enterprise avenue; milaca MN 56353
• MDR Report Key: 9406599
• Report Number: 2937094-2019-61600
• Device Sequence Number: 3232221
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 01/10/2020

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: 0000003680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other