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

Model Number	EM3-60
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The em3-60 cable adapter displayed burned outer insulation, indicating the wire may have broke and burned through the insulation.The cable sparked in the operating room.The location of the failure occured on the foot switching side of the cable.There was no indication of harm to patients or users.

• Brand Name: EM3 MONOPOLAR ADAPTER, UNIVERSAL
• Common Device Name: ELECTROSURGICAL, CUTTING AND COAGULATION, DEVICE AND ACCESSORIES
• Manufacturer (Section D): ENCISION INC.; 6797 winchester circle; boulder CO 80301
• Manufacturer (Section G): ENCISION INC.; 6797 winchester cir; boulder CO 80301
• Manufacturer Contact: danielle kaessner ; 6797 winchester circle; boulder, CO 80301 ; 3034442600
• MDR Report Key: 12863169
• Report Number: 1722040-2021-00003
• Device Sequence Number: 1817136
• Product Code: GEI
• UDI-Device Identifier: 10815288012983
• UDI-Public: 10815288012983
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 10/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown