MAUDE Adverse Event Report: ENCISION INC. EM3 MONOPOLAR ADAPTER, UNIVERSAL; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESORIES

Model Number	EM3-60
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An em3-60 cable adapter, which is connected to an esu and monitoring device, displayed smoke and sparks during a laparoscopic electrosurgical appendectomy procedure.Power from the esu was shut off when the event was detected.No patients or users were harmed during this event or as a result of this event.

• Brand Name: EM3 MONOPOLAR ADAPTER, UNIVERSAL
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESORIES
• Manufacturer (Section D): ENCISION INC.; 6797 winchester circle; boulder CO 80301
• MDR Report Key: 12233399
• Report Number: 1722040-2021-00001
• Device Sequence Number: 3612682
• Product Code: GEI
• UDI-Device Identifier: 10815288012983
• UDI-Public: 10815288012983
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EM3-60
• Device Catalogue Number: EM3-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1