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

Model Number	CD004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic nephrectomy.Event description: cd004 was being used to remove the patient's kidney, the bag had been successfully deployed and the trocars were being removed ready to remove the specimen when the event occurred.The kidney was placed in the bag and the patient was checked for any bleeding before removing all the ports, the retrieval stick was unhooked and removed followed by the port in which the guide bead fell out of the port in to the surgeons hand as it was being removed with the bag still inside the patient.The port site incision was extended and the specimen within the bag was removed.The bag still had the specimen inside therefore once the incision was extended it could be removed without any intervention.Additional information received from applied medical representative via email on 16may25: unfortunately, no video was taken of the incident.Intervention: the bag still had the specimen inside therefore once the incision was extended it could be removed without any intervention.Patient status: patient status is normal.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience component separation as the bead was detached from the bag.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the 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: laparoscopic nephrectomy.Event description: cd004 was being used to remove the "patient's" kidney, the bag had been successfully deployed and the trocars were being removed ready to remove the specimen when the event occurred.The kidney was placed in the bag and the patient was checked for any bleeding before removing all the ports, the retrieval stick was unhooked and removed followed by the port in which the guide bead fell out of the port into the surgeons hand as it was being removed with "the" bag still inside the patient.The port site incision was extended and the specimen within the bag was removed.The bag still had the specimen inside therefore once the incision was extended it could be removed without any intervention.Additional information received from applied medical representative via email on 16may2025: unfortunately, no video was taken of the incident.Intervention: the bag still had the specimen inside therefore once the incision was extended it could be removed without any intervention.Patient status: patient status is normal.

• 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: 22116639
• Report Number: 2027111-2025-00561
• Device Sequence Number: 14480600
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APPLIED TROCAR CFF73
• Patient Sex: Unknown