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

Model Number	CD004
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: nephrectomy.Event description: during deployment of the specimen retrieval bag, when the user advanced the thumb ring to expand the bag, the bag detached prematurely from the support frame before full extension was achieved, requiring replacement with a new device to complete the procedure.There is no impact to the patient.Additional information provided by [name] on 14aug2025: the bag completely fell off the metal supports.The tips of the supports were not exposed inside the patient.The bag fell down the supports during bag manipulation to unroll the bag.Additional information provided by [name] on 18aug2025: when the actuator was advanced to deploy the bag, the bag detached from the support frame.Intervention: user replace with a new one.Patient status: fine.
Event or Problem Description
Procedure performed: nephrectomy.Event description: during deployment of the specimen retrieval bag, when the user advanced the thumb ring to expand the bag, the bag detached prematurely from the support frame before full extension was achieved, requiring replacement with a new device to complete the procedure.There is no impact to the patient.Additional information provided by [name] on 14aug2025: the bag completely fell off the metal supports.The tips of the supports were not exposed inside the patient.The bag fell down the supports during bag manipulation to unroll the bag.Additional information provided by [name] on 18aug2025: when the actuator was advanced to deploy the bag, the bag detached from the support frame.Intervention: user replace with a new one.Patient status: fine.
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supports.Based on the condition of the returned unit and the description of the event, it is likely that the actuator was retracted before full deployment.This likely caused the bag to fall or partially slip off its supports.Subsequently, when distal force was applied during bag unrolling, the bag fully slipped off the supports.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.

• 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: 22968206
• Report Number: 2027111-2025-00740
• Device Sequence Number: 15705131
• 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): 11/26/2025

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: 1549672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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