MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS CONTAINED EXTRACTION SYSTEM WITH KII BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	GTK17
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Initial balloon was defective requiring operating team member to obtain a new one and this one worked fine.No adverse problems for the patient resulted with the defective balloon.The sales representative was contacted regarding this event.

• Brand Name: ALEXIS CONTAINED EXTRACTION SYSTEM WITH KII BALLOON BLUNT TIP SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 22327013
• Report Number: 22327013
• Device Sequence Number: 18214955
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: 20607915134826
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025
• Report Date (Section F): 06/19/2025

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: GTK17
• Device Lot Number: 1552384
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 06/19/2025