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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: left nephrectomy.Event description: medwatch form fda-3500a #: (b)(4).Pt procedure left nephrectomy.Kidney was placed in an alexis contained extraction system, lot 1565072, exp 05/27/28.2 pieces broke off from the bag when removing the kidney through the abdomen.2 pieces retrieved.Surgeon verified through open incision exploration & via laparoscopy.No retained pieces seen.Supply is no radio opaque.Additional information provided by [name] on 24oct2025 via email: no patient injury.Patient's status is discharged.Event date is 9/15/25.Unfortunately, the staff did not save it (the device).It was the specimen containment bag part that ripped and pieces fell off.Additional information provided by [name] on 24oct2025: the orientation of the bag inside the patient¿s body was right side up-with the opening facing the ceiling.I don¿t recall if the bag was fan folded or rolled.I don't think i understand this but the bag was fully open/deployed.Intervention: 2 pieces retrieved.No retained pieces seen.Patient status: no patient injury indicated.Discharged.
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.This report is to follow-up medwatch # (b)(4).
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.This report is to follow-up medwatch # 2201630000-2025-8051.
Event or Problem Description
Procedure performed: left nephrectomy.Event description: medwatch form fda-3500a #2201630000-2025-8051.Pt procedure left nephrectomy.Kidney was placed in an alexis contained extraction system, lot 1565072, exp 05/27/28.2 pieces broke off from the bag when removing the kidney through the abdomen.2 pieces retrieved.Surgeon verified through open incision exploration & via laparoscopy.No retained pieces seen.Supply is no radio opaque.Additional information provided by [name]on 24oct2025 via email: no patient injury.Patient's status is discharged.Event date is 9/15/25.Unfortunately the staff did not save it (the device).It was the specimen containment bag part that ripped and pieces fell off.Additional information provided by [name] on 24oct2025: the orientation of the bag inside the patient¿s body was right side up-with the opening facing the ceiling.I don¿t recall if the bag was fan folded or rolled.I don't think i understand this but the bag was fully open/deployed.Intervention: 2 pieces retrieved.No retained pieces seen.Patient status: no patient injury indicated.Discharged.

• 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: 23621397
• Report Number: 2027111-2025-00878
• Device Sequence Number: 18404958
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Device Lot Number: 1565072
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Race: White