MAUDE Adverse Event Report: ENCISION INC. FC0311+; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number FC0311+

Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

During a lap chole procedure, the user reported that flecks of insulation at the tip of the disposable fixed-tip electrode (part number fc0311+) were sheared off.The customer reported that flecks of the material fell into the patient and had to be retrieved.There was no report of injury or death.

• Brand Name: FC0311+
• Type of Device: 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: 17541637
• MDR Text Key: 321166142
• Report Number: 1722040-2023-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10815288014215
• UDI-Public: 10815288014215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: FC0311+
• Device Catalogue Number: FC0311+
• Device Lot Number: CKH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention