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

Model Number	CD005
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	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni event description: surgeon somewhat new to using model cd005 and during surgery became concerned that she did not see a guide bead.Therefore, she decided to use a new bag, which did have a visible bead.Due to this, they did an x-ray on the patient and did not see any particulate inside the patient.Additional information provided by [name] on 05feb2026 via email: after consulting with the surgeon, we determined that the deployment button was not pushed at the correct time.The surgeon was attempting to deploy the bag and expected to see the guide bead but was unable to visualize it.The guide bead was not visible because the deployment button was not activated at the appropriate time, which would have triggered the bag¿s final deployment and exposed the guide bead.Yes, this occurred before the activation of the delta button.Based on discussion with the team, it appears there was confusion about when the activation button should be pushed.Note: this was the email from the customer; last week, dr.[name] had a case where she was using one of these bags, lot # 1536457.During the case, dr.[name] did not see a bead at the top of the bag to cinch the bag.She thought maybe these did not come with a bead, but she used another bag on her next case, and that one did have the bead.They had to x-ray the previous patient to rule out the possibility of the bead being left inside the patient.Unfortunately, the first bag was discarded after the case.Intervention: used a new device.Patient status: no patient injury.
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.

• Brand Name: INZII RIPSTOP REDEPLOYABLE 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: 25059641
• Report Number: 2027111-2026-00536
• Device Sequence Number: 10100708
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K232880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: CD005
• Device Catalogue Number: 101475688
• Device Lot Number: 1536457
• 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: 01/29/2026
• Initial Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 02/19/2025
• 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