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

Model Number	CD004
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic partial nephrectomy surgery.Event description: during the surgery, a green bead was found stuck at the opening of the ctr33.After the user removed the specimen bag, they discovered that the bead was blocking the bag from being properly tightened.The hospital has since discarded the unit.There is no impact to patient.Additional information provided by [name] on 08apr2025 via email: we would like to inform you that an error occurred in the product model details initially submitted, due to incorrect information provided by the sales representative.While the product belongs to the same category, the model number and size were misstated in the original complaint report.Please note that the model number has been updated from cd001 to cd004.Please find attached the corrected version of the complaint report with the accurate product model indicated.Below are our responses to your questions, with our replies marked in red for your reference.No spillage out of the bag opening.The guide bead was not pulled on with an instrument.The guide bead did not detach from the bag.The guide bead did not detach from the cord.The guide bead remained attached to the cord, but it became stuck and failed to properly close the specimen bag opening.Intervention: no intervention required.Patient status: fine.There is no impact to patient.
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: robotic partial nephrectomy surgery.Event description: during the surgery, a green bead was found stuck at the opening of the ctr33.After the user removed the specimen bag, they discovered that the bead was blocking the bag from being properly tightened.The hospital has since discarded the unit and attached are two photos from that time.There is no impact to patient.Additional information provided by [name] on 08apr2025 via email: we would like to inform you that an error occurred in the product model details initially submitted, due to incorrect information provided by the sales representative.While the product belongs to the same category, the model number and size were misstated in the original complaint report.Please note that the model number has been updated from cd001 to cd004.Please find attached the corrected version of the complaint report with the accurate product model indicated.Below are our responses to your questions, with our replies marked in red for your reference.No spillage out of the bag opening.The guide bead was not pulled on with an instrument.The guide bead did not detach from the bag.The guide bead did not detach from the cord.The guide bead remained attached to the cord, but it became stuck and failed to properly close the specimen bag opening.Intervention: no intervention required.Patient status: fine.There is no impact to patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos were provided, confirming the complainant¿s experience of bag did not cinch.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.

• 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: 21954534
• Report Number: 2027111-2025-00506
• Device Sequence Number: 18238269
• 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): 10/30/2025

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: 1543702
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CTR33.
• Patient Sex: Unknown