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	04/09/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: right lower lobectomy.Event description: the bag was used to retrieve the lobectomie from the chest cavity.During the pull out the guidance ball fell into the cavity and got detached from the bag.The bag was already disposed off before the ball was found, they kept the ball, and are going to clean it if you need it returned.Additional information received from customer via email on 10apr25: event: context of lower lobectomy by vats.During haemostasis by lymph node dissection, the surgeon accidentally discovered the guide ball in the patient's chest (the staff had not noticed this when they left the operating room).Ball removed from the patient's chest, no effect.The green ball in question is at the pharmacy if necessary for referral or expertise.The other part of the device was unfortunately thrown away or sent to the anatomical pathology laboratory.Additional information received from applied medical representative via email on 16apr25: the bag didn't seem to be ripped in any way or at least ripped in a way that affected the procedure.Actually, the surgeon and anyone that was there, including myself, did not notice that the bead "broke" right until the end of the procedure where they found the bead inside the patient before closing.So, what happened was that the bead was removed and nothing affected the procedure nor the outcome.As per the bag it was already disposed of and we couldn't fish it back from the trach to investigate it as it was very dirty and already taken away.As for the bead that is still there, i will give you the contact of the people in the or and the address of the hospital so that you can send a box to retrieve it.Intervention: ball removed from the patient's chest, no effect.Patient status: patient is not affected.
Event or Problem Description
Procedure performed: right lower lobectomy.Event description: the bag was used to retrieve the lobectomie from the chest cavity.During the pull out the guidance ball fell into the cavity and got detached from the bag.The bag was already disposed off before the ball was found, they kept the ball and are going to clean it if you need it returned.Additional information received from customer via email on 10apr25: event: context of lower lobectomy by vats.During haemostasis by lymph node dissection, the surgeon accidentally discovered the guide ball in the patient's chest (the staff had not noticed this when they left the operating room).Ball removed from the patient's chest, no effect.The green ball in question is at the pharmacy if necessary for referral or expertise.The other part of the device was unfortunately thrown away or sent to the anatomical pathology laboratory.Additional information received from applied medical representative via email on 16apr25: the bag didn't seem to be ripped in any way or at least ripped in a way that affected the procedure.Actually, the surgeon and anyone that was there, including myself, did not notice that the bead "broke" right until the end of the procedure where they found the bead inside the patient before closing.So, what happened was that the bead was removed and nothing affected the procedure nor the outcome.As per the bag it was already disposed of and we couldn't fish it back from the trach to investigate it as it was very dirty and already taken away.As for the bead that is still there, i will give you the contact of the people in the or and the address of the hospital so that you can send a box to retrieve it intervention: ball removed from the patient's chest, no effect.Patient status: patient is not affected.
Additional Manufacturer Narrative
A portion of the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience component separation, as the bead assembly was returned 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 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: 21990195
• Report Number: 2027111-2025-00519
• Device Sequence Number: 8312229
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• 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: 1537636
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: ALEXIS
• Patient Sex: Unknown