MAUDE Adverse Event Report: NORTECH SYSTEMS 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	01/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during pretreatment, with a patient under anesthesia, a code was received to replace the delivery device for the first two devices used.A third and fourth delivery device were tried but both devices were not recognized and no code was received.The procedure was not completed as a result of the device issues.There was no patient harm.
Event or Problem Description
It was reported that during pretreatment, with a patient under anesthesia, a code was received to replace the delivery device for the first two devices used.A third and fourth delivery device were tried but both devices were not recognized and no code was received.The procedure was not completed as a result of the device issues.There was no patient harm.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The reported failure to recognize the delivery device issue was confirmed.Analysis of the device revealed a dislodged pin on the p2 connector of the delivery device cable and the cable was replaced.The generator received all required updates as and passed full functional and electrical safety testing.Due to the observed dislodged p2c connector, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.The generator passed all functional testing at the time of release from manufacturing.Therefore, it can be concluded that the broken pin (open electrical circuit) was the most probable cause of this complaint.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS INC.; nw 7791; 1450; minneapolis MN 55485
• MDR Report Key: 9742211
• Report Number: 2937094-2020-00141
• Device Sequence Number: 2483477
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/24/2020

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: 0000003847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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