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

Model Number	CD003
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	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap adnexectomy event description: on 25 june, there was a problem with an inzii bag from applied.Ref cd003, batch 1573509.Problem: a black thread would not come loose after the plunger broke off.This is said to have happened on several occasions.They couldn't take the cord from the hook to release the inzii bag back in the abdomen.First they took adnex out of bag and then they pulled out the bag with deployment system and trocar through the incision.Afterwards they took a new cd003.Type of intervention: they took a new cd003.Patient status: patient ok.
Additional Manufacturer Narrative
The event unit 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: 50181587
• Report Number: 2027111-2026-01731
• Device Sequence Number: 9886567
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1573509
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 11/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5mm Adv Fix Kii
• Patient Sex: Unknown