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

Model Number	CD004
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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: abdominal total hysterectomy.Event description: during the attempted deployment of the bag via actuator extension, the bag completely dislodged from the prongs and fell into the patient's abdominal cavity before the prongs had fully extended beyond the introducer sheath.Additional information obtained from distributor on 30apr2025: the tips of the support were exposed inside the patient.The bag fell down the supports.This occurred immediately upon the full deployment of the actuator.The actuator was not pushed forward, retracted and then fully deployed.Intervention: user replace with a new one to complete this surgery.Patient status: fine.There is no impact to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the specimen bag falling off the metal supports.Based on the condition of the returned unit and the description of the event, it is likely that the actuator was retracted and redeployed multiple times, which resulted in the specimen bag falling off the metal supports upon full deployment.The instructions for use states, "do not retract prior to full deployment." applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: abdominal total hysterectomy.Event description: during the attempted deployment of the bag via actuator extension, the bag completely dislodged from the prongs and fell into the patient's abdominal cavity before the prongs had fully extended beyond the introducer sheath.Additional information obtained from distributor on 30apr2025: the tips of the support were exposed inside the patient.The bag fell down the supports.This occurred immediately upon the full deployment of the actuator.The actuator was not pushed forward, retracted and then fully deployed.Intervention: user replace with a new one to complete this surgery.Patient status: fine.There is no impact to patient.

• 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: 22072179
• Report Number: 2027111-2025-00545
• Device Sequence Number: 9301514
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1534146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Patient Sex: Unknown