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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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: myomectomy.Description of event: [name] and i had a call with dr.[name], an obgyn fellow at [name] in (b)(6), yesterday to discuss her experience using the alexis ces.She relayed that last week her team was performing a myomectomy and when exteriorizing an ~250-500g specimen in the ces, the bag tore.She said they had exteriorized the majority of the ces bag's outer ring and then she experienced resistance, so she used more force to try to exteriorize the remainder of the ring.The bag ended up tearing about 1/3rd of the way down from this force.They were able to pull the full ring out and pull enough of the sheath out that the tear was exteriorized as well.They rolled down the outer ring past this tear and proceeded with the morcellation.They had no further issues and the patient did well.The surgeon was not sure which ces model she was using.Intervention: they rolled down the outer ring past this tear and proceeded with the morcellation.Patient status: no patient injury.
Event or Problem Description
Procedure performed: myomectomy.Description of event: [name] and i had a call with dr.[name], an obgyn fellow at [name] in los angeles, ca, yesterday to discuss her experience using the alexis ces.She relayed that last week her team was performing a myomectomy and when exteriorizing an ~250-500g specimen in the ces, the bag tore.She said they had exteriorized the majority of the ces bag's outer ring and then she experienced resistance, so she used more force to try to exteriorize the remainder of the ring.The bag ended up tearing about 1/3rd of the way down from this force.They were able to pull the full ring out and pull enough of the sheath out that the tear was exteriorized as well.They rolled down the outer ring past this tear and proceeded with the morcellation.They had no further issues and the patient did well.The surgeon was not sure which ces model she was using.Intervention: they rolled down the outer ring past this tear and proceeded with the morcellation.Patient status: no patient injury.
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.

• 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: 20645447
• Report Number: 2027111-2024-00904
• Device Sequence Number: 7432462
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: GTK17
• Device Catalogue Number: 700315186
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 05/16/2025
• 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
• Patient Sex: Unknown