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	03/23/2026
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: robotic cholecystectomy event description: the device was being used to remove specimen.During the procedure, they were having difficulty with the bag-they were able to deploy it, but then it was resisting cinching it back up.The handle/bag fell apart while they were using it, and they had to search for and retrieve the small white round piece.There was no clinical impact to the patient.Additional information provided by [name] but emailed by [name] on 13apr2026: not sure, but we believe no the actuator was not able to be fully retracted.Bag was not able to fully cinch due to size of gallbladder yes-gallbladder was a little too big for the size of the bag.The specimen was gallbladder.Yes, the delta button was pressed before the customer experienced ¿resisting cinching it back up." no, bag would not release to be pulled back up into the tube.No, the specimen was not completely pulled into the tube.Yes, the delta button was pressed and the actuator was fully advanced to fully deploy the tissue bag before the customer experienced ¿resisting cinching it back up." the ¿small white round piece¿ was inside the peritoneal cavity of the patient.The surgeon used a 12mm intuitive cannula with the retrieval system.Intervention: replaced device patient status: no patient injury indicated.

• 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: 24958031
• Report Number: 2027111-2026-00510
• Device Sequence Number: 10093322
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: 1571526
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 12/02/2025
• 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