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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow up report will be provided upon completion of the investigation.
Event or Problem Description
Event date unknown.Procedure performed: laparoscopic bilateral salphing-oopherectomy.Event description: mhra user report: surgeon used the item to assist in specimen retrieval in a laparoscopic case.Upon attempt to pull the retrieval system bag, the surgeon had difficulty so they used other instruments to help remove the bag and the specimen.Once the bag was out, it was inspected and noted a rip part and a hole on it and have noticed a small par of the bag was missing.Surgeon inspected the bag three times and looked for the missing piece inside the abdominal cavity, ports, specimen and suction.Additional information received from applied medical representative via email on (b)(6) 2026: no patient injury.It was resolved by taking the retrieval bag was out, search for the missing piece and done loads of peritoneal wash.No spillage out of the damage to the bag.Yes, the bag did break in tiny piece.Not sure if the fragments were retrieved from the patient.The bag burst during specimen removal.The port size was not enlarged, been retrieve on the 5mm port with 5mm retrieval bag specimen fits within in the bag.Type of intervention: retrieval bag was taken out, search for the missing piece and done loads of peritoneal wash.Patient status: no patient injury reported.

• 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: 25565458
• Report Number: 2027111-2026-00610
• Device Sequence Number: 10012596
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 1570666
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 10/16/2025
• 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: SPENCER WELLS
• Patient Sex: Unknown