MAUDE Adverse Event Report: ENCISION INC. FIXED-TIP ELECTRODE, J-HOOK; ELECTOSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ES3510B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on a visual inspection of the device, the ultem tip broke and detached, likely due to force applied to the tip during the procedure.The manufacture and sale dates of the device suggest that it has been reprocessed for use at least 20 times, which is the verified lifecycle of the device.While the ifu instructs the user to visually inspect the device before use, microscopic fractures in the ultem time that form over time with reuse may not be immediately apparent.However, damaged insulation is stated in the ifu as an end of life indicator.Based on trending data, this is an isolated defect and not indicative of a design flaw.
Event or Problem Description
During a laparoscopic procedure, the tip of the primary ultem insulation cracked from the j-hook fixed-tip electrode and fell into the patient.The two pieces of the insulation were recovered.No injury or death was reported.No further medical intervention was required.

• Brand Name: FIXED-TIP ELECTRODE, J-HOOK
• Common Device Name: ELECTOSURGICAL, CUTTING & COAGULATION & 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: 23827013
• Report Number: 1722040-2025-00001
• Device Sequence Number: 4992732
• Product Code: GEI
• UDI-Device Identifier: 10815288010415
• UDI-Public: 10815288010415
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K912780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: ES3510B
• Device Catalogue Number: ES3510B
• Device Lot Number: CFA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown