MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CD004
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: robot-assisted distal gastrectomy.Event description: "hospital [(b)(6)].This is a complaint from the hospital.When the bag was deployed, the support wire protruded from the bag, so the user determined to stop using the event unit as it is not safe condition.No patient injury or illness associated with this event.Replaced to a new hospital inventory cd004 and procedure was completed.This event unit will be returned." additional information provided by fi personnel via email on 06nov2025: the support tips were exposed inside the patient.Intervention: after confirming no fragment dropped into the abdominal cavity, replaced to a hospital inventory new cd004 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 retrieval bag falling off the metal supports.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the exact cause of the reported event based on the evaluation of the returned unit.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: robot-assisted distal gastrectomy event description: "hospital [name] this is a complaint from the hospital; when the bag was deployed, the support wire protruded from the bag, so the user determined to stop using the event unit as it is not safe condition.No patient injury or illness associated with this event.Replaced to a new hospital inventory cd004 and procedure was completed.This event unit will be returned." additional information provided by fi personnel via email on (b)(6) 2025: the support tips were exposed inside the patient.Intervention: after confirming no fragment dropped into the abdominal cavity, replaced to a hospital inventory new cd004 and the procedure was completed.Patient status: no patient injury or illness associated with this event.

• Brand Name: INZII RETRIEVAL 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: 23622553
• Report Number: 2027111-2025-00881
• Device Sequence Number: 15695372
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060051
• 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): 02/27/2026

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: CD004
• Device Catalogue Number: 101388201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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