MAUDE Adverse Event Report: ENCISION INC. EM3-60; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	EM3-60
Medical Device Problem Codes	Melted (1385); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The em3-60 cable, which is connected to the esu and aem monitor, burned in the operating room during surgery.There were no injuries to patients or users reported.

• Brand Name: EM3-60
• 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 circle; boulder CO 80301
• Manufacturer Contact: danielle kaessner ; 6797 winchester circle; boulder, CO 80301 ; 3034442600
• MDR Report Key: 20278381
• Report Number: 1722040-2024-00002
• Device Sequence Number: 7987419
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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