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

Model Number	GTK14
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: vaginal assisted total laparoscopic hysterectomy.Event description: hospital name: dr.[name]."the surgeon sought to utilize the alexis ces for specimen extraction via the vaginal canal.Following the resection of the uterus, the alexis ces was inserted through the vagina into the abdominal cavity.The vagina was then closed with a pad to facilitate insufflation and to secure the specimen within the bag.The surgeon proceeded to pull on the alexis ces thread in an attempt to extract the specimen.However, due to the size of the specimen, manual morcellation was initiated to reduce its size." "despite his efforts, the specimen remained somewhat large, prompting the surgeon to apply increased force to remove it.After several minutes of strong pulling, the bag became torn along the seam.The surgeon was able to retrieve the specimen by securing it with an open instrument and continued pulling until it was successfully removed.The surgeon acknowledged that the force applied in an attempt to extract the specimen contributed to the rupture of the bag, but i chose to share this incident for your information and review." intervention: the surgeon was able to retrieve the specimen by securing it with an open instrument and continued pulling until it was successfully removed.Patient status: no incident.
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.Based on the description of the event, it is possible that excessive force exerted on the bag during removal caused the bag to tear.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: vaginal assisted total laparoscopic hysterectomy.Event description: hospital name: dr.[name]."the surgeon sought to utilize the alexis ces for specimen extraction via the vaginal canal.Following the resection of the uterus, the alexis ces was inserted through the vagina into the abdominal cavity.The vagina was then closed with a pad to facilitate insufflation and to secure the specimen within the bag.The surgeon proceeded to pull on the alexis ces thread in an attempt to extract the specimen.However, due to the size of the specimen, manual morcellation was initiated to reduce its size." "despite his efforts, the specimen remained somewhat large, prompting the surgeon to apply increased force to remove it.After several minutes of strong pulling, the bag became torn along the seam.The surgeon was able to retrieve the specimen by securing it with an open instrument and continued pulling until it was successfully removed.The surgeon acknowledged that the force applied in an attempt to extract the specimen contributed to the rupture of the bag, but i chose to share this incident for your information and review." intervention: the surgeon was able to retrieve the specimen by securing it with an open instrument and continued pulling until it was successfully removed.Patient status: no incident.

• 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: 21270024
• Report Number: 2027111-2025-00336
• Device Sequence Number: 17122700
• Product Code: GCJ
• UDI-Device Identifier: 20607915137070
• UDI-Public: (01)20607915137070
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 02/25/2025

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: GTK14
• Device Catalogue Number: 700315185
• Device Lot Number: 1530283
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown