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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robot-assisted gastrectomy.Event description: when the handle was push and the specimen bag was deployed, the specimen bag and support wire were separated at first use.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 received 04sep2025 by email from amj ra/qa specialist: i got a response from pic including the additional information as below.The support tips were exposed inside of the patient.However, they did not contact with any organs and abdominal wall.The doctor thinks that the support wire support wire was not inside the slit in the pouch, even though it should have been, so the issue occurred.Intervention: replaced to a hospital inventory new cd004 and the procedure was completed.Patient status: no patient injury indicated.
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 gastrectomy.Event description: when the handle was push and the specimen bag was deployed, the specimen bag and support wire were separated at first use.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 received 04sep2025 by email from amj ra/qa specialist: i got a response from pic including the additional information as below.The support tips were exposed inside of the patient.However, they did not contact with any organs and abdominal wall.The doctor thinks that the support wire support wire was not inside the slit in the pouch, even though it should have been, so the issue occurred.Intervention: replaced to a hospital inventory new cd004 and the procedure was completed.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the specimen 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.

• 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: 22981878
• Report Number: 2027111-2025-00742
• Device Sequence Number: 15795495
• 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): 01/29/2026

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
• Device Lot Number: 1546263
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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 Sex: Unknown