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

Model Number	G2200
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation of the convective radiofrequency water vapor thermal therapy procedure the generator received error 400.Two devices were used to troubleshoot the generator issue while the patient was awaited treatment.The patient was in post sedation under a local anesthesia.The patient had to be rescheduled due to the issues with the equipment.There was no clinical consequences to the patient.
Event or Problem Description
It was reported that during the preparation of the convective radiofrequency water vapor thermal therapy procedure the generator received error 400.Two devices were used to troubleshoot the generator issue while the patient was awaited treatment.The patient was in post sedation under a local anesthesia.The patient had to be rescheduled due to the issues with the equipment.There was no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the console had a strong burnt smell coming from it.Detected the bovie 15w rf power supply was damaged.The generator was received with minor plastic enclosure damage.The rest of the generator was in overall good physical condition.The generator received all required updates.The generator passed full functional and electrical safety testing.Device displays 400 rf power supply error complaint was most likely caused by an electrical failure with the circuits in the bovie 15w rf power supply.The secondary finding of damaged enclosure parts was due to normal usage wear.An evaluation conclusion code of cause traced to component failure 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: 10121218
• Report Number: 2937094-2020-00464
• Device Sequence Number: 19371504
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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