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 Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: kidney removal event description: when removing the patient¿s kidney an alexis bag retrieval system was used.When removing this bag with the kidney inside, the bag was pulled too hard, and the bag broke inside the body.The bag was placed on the back table and the kidney was removed by hand.The cavity was then swept, and 2 more small pieces of the bag retrieval system were found and removed.The robot was then redocked to find the missing lymph node specimen.While docked the cavity was swept again and no more pieces of the bag retrieval system were found.Event date: 7/7/2025.System extraction alexis contained 12x100mm balloon blunt.Mfg # gtk17.Sample available: no.Lot # unknown.Was there injury? no, but product error resulted in the need for increased monitoring there are no samples available.Additional information provided by [name] on 16jul2025 via email: it tore in the corner while pulling out the specimen.Nothing was used inside the bag other than to grasp the specimen and place it inside the bag.Intervention: the bag was placed on the back table and the kidney was removed by hand.Patient status: no injury, but product error resulted in the need for increased monitoring.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided.Visual inspection confirmed that complainant¿s experience of bag tear.Based on the description of the event and the photo provided, it is likely that the specimen was not adequately morcellated before removal, and excessive force may have been used while extracting the containment bag, leading to the bag tearing.Applied medical¿s instructions for use (ifu) states that, ¿if resistance is met during bag removal, then the tissue has not been adequately morcellated.Insufficient morcellation of the specimen could lead to damage of the specimen containment bag upon removal.¿ 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: kidney removal.Event description: when removing the patient¿s kidney an alexis bag retrieval system was used.When removing this bag with the kidney inside, the bag was pulled too hard, and the bag broke inside the body.The bag was placed on the back table and the kidney was removed by hand.The cavity was then swept, and 2 more small pieces of the bag retrieval system were found and removed.The robot was then redocked to find the missing lymph node specimen.While docked the cavity was swept again and no more pieces of the bag retrieval system were found.Event date: 7/7/2025.System extraction alexis contained 12x100mm balloon blunt mfg # gtk17 sample available: no.Lot # unknown.Was there injury? no, but product error resulted in the need for increased monitoring there are no samples available.Additional information provided by [name] on 16jul2025 via email: it tore in the corner while pulling out the specimen.Nothing was used inside the bag other than to grasp the specimen and place it inside the bag.Intervention: the bag was placed on the back table and the kidney was removed by hand.Patient status: no injury, but product error resulted in the need for increased monitoring.

• 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: 22806929
• Report Number: 2027111-2025-00693
• Device Sequence Number: 8960653
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 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: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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
• Patient Sex: Unknown