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	03/07/2025
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: da vinci system nephrectomy.Event description: the green bead on the specimen bag has come off, making it unable to securely close the bag.This instrument has already been discarded by the hospital.The hospital's abnormal material report has been attached for reference.There is no impact to patient.Additional information provided by [name]on 01apr2025: since the bead fell into the specimen bag, no action was taken, and the bag was pulled out directly.The user did not take a photo and cannot provide one.The bead did not fall inside the patient.The bead completely detached from the bag.The cord is in normal condition.When the bag was opened, the bead broke and fell into the specimen bag.There was no spillage out of the bag opening.Intervention: since the bead fell into the specimen bag, no action was taken, and the bag was pulled out directly.Patient status: fine.
Event or Problem Description
Procedure performed: da vinci system nephrectomy.Event description: the green bead on the specimen bag has come off, making it unable to securely close the bag.This instrument has already been discarded by the hospital.The hospital's abnormal material report has been attached for reference.There is no impact to patient.Additional information provided by [name]on 01apr2025: since the bead fell into the specimen bag, no action was taken, and the bag was pulled out directly.The user did not take a photo and cannot provide one.The bead did not fall inside the patient.The bead completely detached from the bag.The cord is in normal condition.When the bag was opened, the bead broke and fell into the specimen bag.There was no spillage out of the bag opening.Additional information provided by [name] on 20may2025: i¿ve reviewed the reply you attached and would like to clarify a small misunderstanding regarding the issue we reported.In our original feedback, we did not mention that the cord had detached or come off entirely.The main issue the user observed was that the green bead attached to the cord had cracked into pieces and was found inside the bag.The cord itself remained intact and in place, but the broken bead suggests there may have been a material or assembly issue.Intervention: since the bead fell into the specimen bag, no action was taken, and the bag was pulled out directly.Patient status: fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.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 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: 21946036
• Report Number: 2027111-2025-00500
• Device Sequence Number: 15654016
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 1538684
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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