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	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis.A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.An evaluation conclusion code of no problem detected of the device was assigned to this investigation.
Event or Problem Description
It was reported that the generator was giving the error message "delivery device is expired." the unit was rebooted and the device was reinserted.The message still persists.They did not have another delivery device.The procedure was aborted; there was a patient involved at the time the procedure was cancelled.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS; 925 enterprise avenue; milaca MN 56353
• MDR Report Key: 9297230
• Report Number: 2937094-2019-61453
• Device Sequence Number: 16734535
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/08/2019

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: 0000003009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other