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

Model Number	CD001
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: procedure performed: robotic thoracic case.Event description: retrieval bag was being deployed in the chest during robotic case.No bag inside the retrieval system.No clinical impact to patient.On 02.02.2026 - additional information received from [name] (territory manager) via email: i was doing a robotic thoracic case.The bed side assistant introduced the system into the chest cavity.I could only see the metal tip of the frame of the bag introducer.At that point, we were unsure if the bag had disconnected from the introducer and was lost in the pleural cavity.We spent a significant amount of time looking for the bag, including xray as the bag contains a rounded suture snugger with metal ring.No bag was eventually found, prompting us to think that the device came with no bag at all.This was disclosed to the patient and family who were very distressed if the bag was still inside the bag.Family was also complaining if the post-operative pain was related to the prolonged time of surgery.Have you ever heard about a faulty system or any other similar complaint? this also created unnecessary distress for all the members of the team involved.So far, i have refused to use the product until further understanding.I am gathering other information.I believe they have kept the device, however the contact is away and other staff who are aware don¿t know where the device is.On 03.02.2026 - additional information received from [name] (territory manager) via email: the lot number is 1556064.I have since learned that multiple 10mm inzii retrieval systems were used during this procedure.The ¿faulty¿ retrieval was used second, so i¿m looking into the possibility that the first device was accidentally used again, therefore had already been deployed and hence no bag.Type of intervention: spent a significant amount of time looking for the bag, including xray as the bag contains a rounded suture snugger with metal ring.No bag was eventually found patient status: patient injury not indicated.(refer to event description).

• 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: 24274460
• Report Number: 2027111-2026-00350
• Device Sequence Number: 13267293
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1556064
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MULTIPLE 10MM INZII RETRIEVAL SYSTEMS; ROBOT
• Patient Sex: Unknown