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

Model Number	GTK17
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: robotic total hysterectomy.Event description: tab came off and ended up in patient's abdomen.Piece was retrieved successfully.Just one piece came off the outer ring.Additional information obtained from account manager via email on 11dec2025: i have been working on gathering more information.I got some more intel but am still working to answer some of your questions.Lot #1550567 tab was located inside the patient¿s body.Case ¿ robotic total hysterectomy.I will let you know once i hear back from my contact.Additional information obtained from account manager via email on 15dec2025: i have attached two pictures of the alexis contained extraction system that had a tab break which can be seen in the photos.The surgeon who had this issue has not replied to emails but is in the or this week.My contact is going to speak with them to get more details to better answer your questions.Intervention: retrieved piece out of patient.Patient status: patient is ok.

• 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; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 23883008
• Report Number: 2027111-2025-00948
• Device Sequence Number: 4671822
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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 Catalogue Number: 700315186
• Device Lot Number: 1550567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown