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
Event or Problem Description
Procedure performed: tlh.Event description: "hospital "[name]".This is a complaint from the hospital; the event unit was used to retrieve the uterus.After retrieving, it was found that the bag was torn, and the fragment might have been left in the patient body.No patient injury or illness associated with this event.This event unit will be returned.Intervention: kept using the event unit and the procedure was completed.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: tlh.Event description: hospital "[name]" this is a complaint from the hospital; the event unit was used to retrieve the uterus.After retrieving, it was found that the bag was torn, and the fragment might have been left in the patient body.No patient injury or illness associated with this event.This event unit will be returned.Intervention: kept using the event unit and the procedure was completed.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 23707270
• Report Number: 2027111-2025-00899
• Device Sequence Number: 13422280
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Was Device Available for Evaluation?: No
• 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: 11/09/2025
• 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): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCISSORS
• Patient Sex: Unknown