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

Model Number	CD005
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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 prostatectomy with lymph nodes.Event description: the bag was being used in redeployable mode to bag and remove individual lymph nodes and pull bag with specimen directly through the 1mm trocar ctf33 while trocar remained in the patient.After several successful specimen removals during the case, the last specimen wasn't fitting through the trocar.However, the attempt to pull the bag through the trocar resulted in a compromised bag.The trocar and bag were removed.Trocar was reintroduced.No negative clinical patient impact.Additional information provided by [(b)(6)] on 30oct2025: it is just the one cd005 unit that malfunctioned.The actual bag was accidently thrown away by the hospital in the cleaning process and only the bag delivery system was cleaned/decontaminated.It was the bag that was damaged, not the delivery system.There wasn¿t any specimen spillage as the bag tore but not where the specimen was located.The bag remained in one piece but tore or gave way in the center of the bag under the pressure of attempting to remove the bag with specimen directly through the trocar, not the incision.It wouldn¿t fit into the trocar.At that point the bag was still connected to the delivery system and the trocar and delivery system were removed simultaneously through the incision.They were using the bag in it¿s redeployable function and not in the final specimen removal of the case through the incision.Intervention: device (bag) was replaced and the case continued.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
A portion of the event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be confirmed as the specimen bag was not returned with the event unit.Based on the description of the event, it is likely that the reported event was caused by additional stress being applied to the bag during specimen removal.The instructions for use (ifu) states, ¿do not apply excessive force or attempt to extract a specimen larger than the trocar cannula when pulling the closed specimen bag through the trocar." applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: robotic prostatectomy with lymph nodes.Event description: the bag was being used in redeployable mode to bag and remove individual lymph nodes and pull bag with specimen directly through the 1mm trocar ctf33 while trocar remained in the patient.After several successful specimen removals during the case, the last specimen wasn't fitting through the trocar.However, the attempt to pull the bag through the trocar resulted in a compromised bag.The trocar and bag were removed.Trocar was reintroduced.No negative clinical patient impact.Additional information provided by [name] on 30oct2025: it is just the one cd005 unit that malfunctioned.The actual bag was accidently thrown away by the hospital in the cleaning process and only the bag delivery system was cleaned/decontaminated.It was the bag that was damaged, not the delivery system.There wasn¿t any specimen spillage as the bag tore but not where the specimen was located.The bag remained in one piece but tore or gave way in the center of the bag under the pressure of attempting to remove the bag with specimen directly through the trocar, not the incision.It wouldn¿t fit into the trocar.At that point the bag was still connected to the delivery system and the trocar and delivery system were removed simultaneously through the incision.They were using the bag in it¿s redeployable function and not in the final specimen removal of the case through the incision.Intervention: device (bag) was replaced and the case continued.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: 23622465
• Report Number: 2027111-2025-00879
• Device Sequence Number: 18632500
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Non-Healthcare 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: CD005
• Device Catalogue Number: 101475688
• Device Lot Number: 1562342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• 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