MAUDE Adverse Event Report: Applied Medical Resources Inzii Retrieval System; Laparoscope, General & Plastic Surgery

Model Number	CD003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: bilateral oophorectomy.Event description: inzii universal bag was deployed into the abdomen to collect the specimen (right ovary).They placed the right ovary into the bag and closed it shut.When they went to pull the bag out with the specimen in it the ovary was no longer in the bag.They are saying that they believe the bag popped or had a hole in it and the right ovary slipped out.They removed the bag with the ovary and then began searching around and through the bowls to find the detached right ovary.They searched for a while and could not find it.They decided it was best to close instead of performing a laparotomy to remove the right ovary.Patient was getting this procedure because it was a risk reduction as she has had cancer twice in the past.Gyn onc is now saying they are doing surgery again to go look and remove the right ovary.Patient is undergoing an additional surgery to find and remove the specimen.Her gyn onc said it is not safe as a cancer risk patient to have her ovary floating around in the abdomen.She said she is undergoing an additional surgery because the bag did not perform how it is supposed to.The issue has yet to be resolved.Patient will undergo surgery again soon to find the right ovary and remove it.Additional information provided by "[name]" via email on 08jul2026: the bag did not break into multiple pieces.The bag did not burst during specimen removal.They said they closed the bag, but when they pulled the bag out, there was no longer a specimen in it.They said there must've been a hole in the bag but didn't check because they were so worried about finding the lost specimen.They did not look where the back broke before throwing the bag away.No pictures were provided as they just called me today and this happened on (b)(6) 2026.Intervention: the issue has yet to be resolved.Patient will undergo surgery again soon to find the right ovary and remove it.Patient status: ni.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.This report serves as initial report for complaint (b)(4).

• 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 (Section G): Applied Medical Resources; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; +1(949)713-5359
• MDR Report Key: 50178709
• Report Number: 2027111-2026-01710
• Device Sequence Number: 12829722
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K100959
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1525199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 06/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown