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

Model Number	EM3-60
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A transfer cable used in electrosurgery had an insulation breach which resulted in a visible flame.This is the third time a cable has failed in the field, though this is the only one that resulted in a flame.This failure mode is being trended.The cable is non-patient contact, the failure resulted in no injuries only a delay in surgery.

• Brand Name: EM3 MONOPOLAR ADAPTER, UNIVERSAL
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): ENCISION INC.; 6797 winchester cir.; boulder CO 80301
• MDR Report Key: 10561301
• Report Number: 1722040-2020-00001
• Device Sequence Number: 3123967
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1