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	10/28/2025
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 upon the completion of the investigation.
Event or Problem Description
Procedure performed: robotic nephrectomy.Event description: after removal from body, we noticed a piece of the bag was missing, it had snapped from string of bag and was left in the patient's body.The surgeon had to re-insufflate the patient in order to visualize the missing piece and retrieve it.Additional information provided by [name] on 04nov2025: the bag itself wasn't damaged; there was no spillage and the bag didn't burst.Part of the green plastic on the introducer is what broke off, this is a safety issue if it was to fall in the patient.The bag was wrapped in a red biohazard bag so i couldn't see exactly where it broke but will have it shipped back once i receive a box.Intervention: had to insufflate again patient to remove missing piece.Patient status: patient is all good.
Event or Problem Description
Procedure performed: robotic nephrectomy.Event description: after removal from body, we noticed a piece of the bag was missing, it had snapped from string of bag and was left in the patient's body.The surgeon had to re-insufflate the patient in order to visualize the missing piece and retrieve it.Additional information provided by [name] on 04nov2025: the bag itself wasn¿t damaged, there was no spillage and the bag didn¿t burst.Part of the green plastic on the introducer is what broke off, this is a safety issue if it was to fall in the patient.The bag was wrapped in a red biohazard bag so i couldn¿t see exactly where it broke but will have it shipped back once i receive a box.Intervention: had to insufflate again patient to remove missing piece.Patient status: patient is all good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of component separation as the bead was detached from the retrieval 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.

• 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: 23649849
• Report Number: 2027111-2025-00887
• Device Sequence Number: 10055335
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 1560932
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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