MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS® CONTAINED EXTRACTION SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	GTB14
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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: unk.Event description: "hospital [name].This is a complaint from the hospital: the wound retractor was torn because a robot arm was contacted with.As it was torn in the bag so it seems that all fragments were collected but the user asked us to reconfirm whether all fragments were collected.No patient injury or illness associated with this event.After collecting the fragments and procedure was completed.This event unit will be returned." intervention: after collecting the fragments and the procedure was completed.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of bag tear.Based on the condition of the returned unit and the description of the event, it is likely that a sharp object or instrument came into contact with the sheath, resulting in holes or tears that further propagated due to the stress experienced by the sheath.The instructions for use (ifu) states, ¿repeated cutting against the guard system may cause damage and may compromise the ability of the guard to protect the integrity of the specimen containment bag¿.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: unk.Event description: "hospital [name].This is a complaint from the hospital; the wound retractor was torn because a robot arm was contacted with.As it was torn in the bag so it seems that all fragments were collected but the user asked us to reconfirm whether all fragments were collected.No patient injury or illness associated with this event.After collecting the fragments and procedure was completed.This event unit will be returned." additional information provided by fi personnel via email on 29jan2026: was the retractor deployed through the alexis ces containment bag? yes was the guard used during the procedure? no intervention: after collecting the fragments and the procedure was completed.Patient status: no patient injury indicated.

• Brand Name: ALEXIS® CONTAINED EXTRACTION 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: 23707023
• Report Number: 2027111-2025-00898
• Device Sequence Number: 10641393
• Product Code: GCJ
• UDI-Device Identifier: 00607915134273
• UDI-Public: (01)00607915134273
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: GTB14
• Device Catalogue Number: 101475754
• Device Lot Number: 1549187
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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