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

Model Number	CD004
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: nephrectomy.Event description: when pushing the thumb ring forward to deploy the bag from the introducer shaft, the support frame fully extended but a significant portion of the bag remained trapped within the shaft, preventing complete expansion.This instrument has already been discarded by the hospital.Additional information provided via email by distributor on 28apr2025: since the incident occurred last year, the customer no longer remembers whether it was difficult to push the actuator at the time.Additional information provided via email by distributor on 06may2025: unfortunately, the user discarded the physical item, so we couldn¿t take photos of it.They only captured the model and batch number from the sterile packaging.The distal portion of the bag was still inside the shaft when it was reported ¿a significant portion of the bag remained trapped within the shaft." intervention: user replace with a new one to complete this surgery.Patient status: fine.There is no impact to patient.
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 trends were identified.
Event or Problem Description
Procedure performed: nephrectomy.Event description: when pushing the thumb ring forward to deploy the bag from the introducer shaft, the support frame fully extended but a significant portion of the bag remained trapped within the shaft, preventing complete expansion.This instrument has already been discarded by the hospital.Additional information provided via email by distributor on 28apr2025: since the incident occurred last year, the customer no longer remembers whether it was difficult to push the actuator at the time.Additional information provided via email by distributor on 06may2025: unfortunately, the user discarded the physical item, so we couldn¿t take photos of it.They only captured the model and batch number from the sterile packaging.The distal portion of the bag was still inside the shaft when it was reported ¿a significant portion of the bag remained trapped within the shaft." intervention: user replace with a new one to complete this surgery.Patient status: fine.There is no impact to patient.

• 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: 22074905
• Report Number: 2027111-2025-00549
• Device Sequence Number: 15631107
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 1534146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown