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); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robot nefrectomy event description: looping cord broke off locking mechanism during tightening/pulling bag.Additional information received from applied medical representative via email on 11dec25: some questions were not answered by them, so there are some blanks.They couldn¿t answer the questions about the location of the cord break relative to the bead.This is because they don¿t know what the bead is.Patient status (under anesthesia).There were no cord fragment(s) that fell into the patient.The break occurred on one side where it is attached to the green element.The cord had come loose on one side, preventing the bag from closing.Ultimately there was spillage, extra bags were used to remove everything from the patient.Type of intervention: unknown patient status: no patient injury reported.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
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: robot nefrectomy.Event description: looping cord broke off locking mechanism during tightening/pulling bag.Additional information received from applied medical representative via email on 11dec25: some questions were not answered by them, so there are some blanks.They couldn¿t answer the questions about the location of the cord break relative to the bead.This is because they don¿t know what the bead is.Patient status (under anesthesia).There were no cord fragment(s) that fell into the patient.The break occurred on one side where it is attached to the green element.The cord had come loose on one side, preventing the bag from closing.Ultimately there was spillage, extra bags were used to remove everything from the patient.Additional information was received from an applied medical representative via email on 17dec25: confirmed the hospital had disposed the device.Type of intervention: unknown.Patient status: no patient injury reported.

• 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: 23873835
• Report Number: 2027111-2025-00946
• Device Sequence Number: 14881058
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 1553498
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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