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

Model Number	CD001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: ni event description: there was an addition bag that broke last evening on (b)(6) 2025.However, i do not have the information from the report and was told it will not be available until possibly monday.Additional information received on 12aug2025 by (account manager) via email: as of right now, there is not additional information for me to share.I am continuing to pursue answers for the questions below.I will keep you posted.Additional information received on 14aug2025 by account manager via email: unknown if there was spillage.The bad did not break into pieces.The bag did burse during specimen removal.It was a prostate being removed.Unknown if the size port was enlarged.10mm bag - lot #1550874 and lot#1545920 were both used in this case.One of the bags broke and the second bag was used without issue.Unfortunately, they were not able to distinguish which was the bag that broke.It did not fragment according to the hospital report.No photos available.Intervention: the second bag was used without issue.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: ni.Event description: there was an addition bag that broke last evening on (b)(6) 2025.However, i do not have the information from the report and was told it will not be available until possibly monday.Additional information received on (b)(6) 2025 by (account manager) via email: as of right now, there is not additional information for me to share.I am continuing to pursue answers for the questions below.I will keep you posted.Additional information received on 14aug2025 by account manager via email: unknown if there was spillage.The bad did not break into pieces.The bag did burse during specimen removal.It was a prostate being removed.Unknown if the size port was enlarged.10mm bag - lot #1550874 and lot#1545920 were both used in this case.One of the bags broke and the second bag was used without issue.Unfortunately, they were not able to distinguish which was the bag that broke.It did not fragment according to the hospital report.No photos available intervention: the second bag was used without issue.Patient status: no patient injury indicated.

• 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: 22917905
• Report Number: 2027111-2025-00729
• Device Sequence Number: 13234835
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: CD001
• Device Catalogue Number: 100864401
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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