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)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: lap chole.Event description: the bag was being used to take out the gall bladder.After the bag was deployed, retracted, and being pulled out through the incision it broke from the bottom into 3 pieces.2 of those pieces needed to be retrieved from the body cavity.Before the specimen was placed into the bag the surgeon used his robotic bi-polar device to help unroll the bag to make space for the gall bladder.Device was replaced with a different competitive bag and the specimen removed, then the pieces of the inzii bag were found and removed from the patient.Additional information provided by [name] on 29may2026 via email: patient status is unknown but no concerns or injuries were mentioned by the dr.After the case during our meeting.Yes, bile and tissue spilled out of the bag when it broke.Intervention: device was replaced with a different competitive bag and the specimen removed, then the pieces of the inzii bag were found and removed from the patient.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: 25629929
• Report Number: 2027111-2026-00617
• Device Sequence Number: 17617943
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 1584060
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 03/18/2026
• 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: CASE TOOK PLACE ON THE ROBOT.; ROBOTIC BI-POLAR DEVICE.
• Patient Sex: Unknown