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

Model Number	CD001
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	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap chole event description: pictured plastic piece (guide bead?) fell off from the bag inside the patient.The piece was retrieved from the patient.The device was used in the procedure.Additional information provided by [name] on (b)(6) 2026: pictured plastic piece (guide bead?) fell off the bag inside the patient.Bag was utilized to take specimen out and when surgeon was doing her final check, look around inside abdomen then saw this plastic piece.Plastic piece retrieved from patient¿s body without any injury.No other product was used to replace the bag during the procedure.There was no spillage out of the bag opening.The guide bead was not pulled on with an instrument.The guide bead did not detach from the bag.The guide bead did not detach from the cord.Yeah turns out, the event was on (b)(6) 2026.It was first reported to me on 1/12/26.Intervention: case completed patient status: no patient injury indicated.
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.

• 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: 24319686
• Report Number: 2027111-2026-00361
• Device Sequence Number: 13300444
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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
• Device Lot Number: 1560307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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
• Patient Sex: Unknown