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

Model Number	CD001
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	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic bso.Event description: the device was deployed to remove tube and ovary's from the patient.The deployment of the bag occurred as normal however with more caution due to previous issues of the bead coming off during deployment, therefore slowly the stick was deployed with the bag opening and the specimen being placed inside, the handle could not be pulled back and the scrub nurse took over to fully deploy the bag to the end of the ratchet system and then pulled the handle all the way back to expose the thread, unloop the cord and remove the stick followed by the trocar.When removing the stick, the bead fell out of the stick and was fully separated from the bag itself.The bead was in two parts and not as one bead.From previous incidences the bead is now included on the scrub techs count and so the bead is accounted for in all cases where it is used to avoid foreign body being left inside a patient.Intervention: from previous incidences the bead is now included on the scrub techs count and so the bead is accounted for in all cases where it is used to avoid foreign body being left inside a patient.Patient status: patient status normal.
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: laparoscopic bso.Event description: the device was deployed to remove tube and ovary's from the patient.The deployment of the bag occurred as normal however with more caution due to previous issues of the bead coming off during deployment, therefore slowly the stick was deployed with the bag opening and the specimen being placed inside, the handle could not be pulled back and the scrub nurse took over to fully deploy the bag to the end of the ratchet system and then pulled the handle all the way back to expose the thread, unloop the cord and remove the stick followed by the trocar.When removing the stick, the bead fell out of the stick and was fully separated from the bag itself.The bead was in two parts and not as one bead.From previous incidences the bead is now included on the scrub techs count and so the bead is accounted for in all cases where it is used to avoid foreign body being left inside a patient.Intervention: from previous incidences the bead is now included on the scrub techs count and so the bead is accounted for in all cases where it is used to avoid foreign body being left inside a patient.Patient status: patient status normal.
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.

• 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: 22341670
• Report Number: 2027111-2025-00607
• Device Sequence Number: 9104557
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1532771
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: APPLIED 11MM TROCAR
• Patient Sex: Unknown