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	11/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was giving error message.The generator was rebooted several times and the same message came up with the same error message.A patient was reported to be involved at the time of the observed issues.The procedure was not completed do to the reported event.There was no patient complications.
Event or Problem Description
It was reported that the device was giving error message.The generator was rebooted several times and the same message came up with the same error message.A patient was reported to be involved at the time of the observed issues.The procedure was not completed do to the reported event.There was 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 revealed an error code 219 (resonant frequency less than 410 khz or greater than 460 khz) during the priming of the delivery device.The device was further inspected and found that the a connector from the step motor for the peristatic pump was partially disconnected.The connector was reseated and the issue was resolved.The generator received all required updates and passed full functional and electrical safety testing.The cause of the dislodged connector could not be determined, therefore, an evaluation conclusion code of cause not established was assigned to this complaint.

• 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: 9376883
• Report Number: 2937094-2019-61571
• Device Sequence Number: 13587043
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 0000003599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 06/23/2020
• 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