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	10/31/2025
Type of Reportable Event	Malfunction
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: robotic lap chole.Event description: upon deployment, the bag was used correctly, but when the scrub tech pressed down on the final deployment button and went to pull back and close it, it would not close and the white part of the inside of the bag was loose.They pushed the bag back in and then used an anchor bag.When the bag was later pulled out to check what had occurred, the white piece fell onto the or floor.Additional information provided by [name] on 31oct2025 via email: the correct model number is cd005.No piece of the instrument fell into the patient.The white piece of deployment system fell off outside of the patient intervention: replaced with an [competitor] bag.Patient status: no patient injury.
Event or Problem Description
Procedure performed: robotic lap chole.Event description: upon deployment, the bag was used correctly, but when the scrub tech pressed down on the final deployment button and went to pull back and close it, it would not close and the white part of the inside of the bag was loose.They pushed the bag back in and then used an anchor bag.When the bag was later pulled out to check what had occurred, the white piece fell onto the operating room floor.Additional information provided by [name] on 31oct2025 via email: the correct model number is cd005.No piece of the instrument fell into the patient.The white piece of deployment system fell off outside of the patient.Intervention: replaced with an [competitor] bag.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, confirming the complainant¿s experience of component separation.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 relevant documentations were identified.

• 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: 23652460
• Report Number: 2027111-2025-00890
• Device Sequence Number: 4824985
• 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): 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): 04/07/2026

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: 1560080
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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