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

Model Number	GTB14
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ratlh.Event description: the porch tore from the ring and half of it came off.No patient injury or illness associated with this event.Replaced a new hospital inventory gtb14 and procedure was completed.This event unit will be returned.Intervention: replaced to a hospital inventory new gtb14 and the procedure was completed.Patient status: no patient injury or illness associated with this event.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ratlh.Event description: the porch tore from the ring and half of it came off.No patient injury or illness associated with this event.Replaced a new hospital inventory gtb14 and procedure was completed.This event unit will be returned.Intervention: replaced to a hospital inventory new gtb14 and the procedure was completed.Patient status: no patient injury or illness associated with this event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the bag separating from the ring.Based on the condition of the returned unit and the description of the event, it is likely that the sheath was not properly heat sealed to the ring during manufacturing, causing a weak or incomplete film-to-ring seal.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were 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: 21954342
• Report Number: 2027111-2025-00504
• Device Sequence Number: 8548171
• 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): 10/24/2025

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: GTB14
• Device Catalogue Number: 101475754
• Device Lot Number: 1538610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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