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

Model Number	CD001
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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: partial nephrectomy.Event description: the issue occurred with two units of the inzii retrieval system during surgery.For both units, when the user pushed the thumb ring forward to advance the bag, the bag immediately detached.The black cord was not connected to the actuation rod and separated completely, making the device unusable.The same issue occurred with the second unit.The procedure was only completed successfully after switching to a third unit.Unfortunately, the hospital did not retain the two defective units, so we are unable to return them to applied for evaluation.There is no impact to patient.Additional information provided by [name] on 31jul2025: the two units were not lost as initially reported.They are now being shipped back to our taipei headquarters from the customer site in southern taiwan.Upon arrival in taipei, we will arrange return shipment to applied medical for your evaluation.Additional information provided by [name] on 04aug2025: yes, the bag completely fell off the supports.The tips of the supports were slightly exposed inside the patient.No, there was no spillage out of the bag opening.When the bag fell off, it was still at the initial stage of use.The bag had not yet been deployed and therefore could not be used.The guide bead was not pulled on with an instrument.The guide bead detached from the bag.The bag was curled when it detached, so it was not possible to determine whether there was any damage or tear under the bead.The guide bead did not detach from the cord.The bead component did not separate inside or outside of the patient.The customer did not take any photos at the time of the incident.The retrieval device will be returned to applied medical for further evaluation.Intervention: user replace with a new one to complete this surgery.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 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: partial nephrectomy.Event description: the issue occurred with two units of the inzii retrieval system during surgery.For both units, when the user pushed the thumb ring forward to advance the bag, the bag immediately detached.The black cord was not connected to the actuation rod and separated completely, making the device unusable.The same issue occurred with the second unit.The procedure was only completed successfully after switching to a third unit.Unfortunately, the hospital did not retain the two defective units, so we are unable to return them to applied for evaluation.There is no impact to patient.Additional information provided by [name] on 31jul2025: the two units were not lost as initially reported.They are now being shipped back to our taipei headquarters from the customer site in southern taiwan.Upon arrival in taipei, we will arrange return shipment to applied medical for your evaluation.Additional information provided by [name] on 04aug2025: yes, the bag completely fell off the supports.The tips of the supports were slightly exposed inside the patient.No, there was no spillage out of the bag opening.When the bag fell off, it was still at the initial stage of use.The bag had not yet been deployed and therefore could not be used.The guide bead was not pulled on with an instrument.The guide bead detached from the bag.The bag was curled when it detached, so it was not possible to determine whether there was any damage or tear under the bead.The guide bead did not detach from the cord.The bead component did not separate inside or outside of the patient.The customer did not take any photos at the time of the incident.The retrieval device will be returned to applied medical for further evaluation.Additional information provided by [name] on 12sep2025: i have forwarded your inquiry to our sales representative and requested that they follow up with the hospital to verify the situation.Additionally, the sales representative has confirmed that the two products in question are indeed the actual units involved in the complaint cases.As soon as i receive further information, i will provide you with an update.Thank you for your patience and understanding.Additional information provided by [name] on 15sep2025: we have revisited this matter with the customer and better understand the miscommunication that occurred.It appears that when initially asked about the guide bead, the customer may have been preoccupied and misinterpreted the question, believing we were inquiring about the detachment between the actuation rod and the bag assembly rather than specifically about the guide bead itself.We can now confirm that the actual issue aligns with the original complaint: in both cases, the entire bag assembly (including the guide bead still properly attached) detached from the actuation mechanism during use when the thumb ring was advanced.The guide bead did not separate from the bag.Additional information provided by [name] on 23sep2025: they confirmed that their standard operating procedure follows the recommended steps, and they did not perform any intentional action to disengage or remove the proximal end of the black cord from its retention hook during the procedure.The reported event occurred during routine use, consistent with their normal practice.The customer's focus was on the surgical task, and they did not specifically observe the status of the cord's attachment to the hook prior to the failure.Intervention: user replace with a new one to complete this surgery.Patient status: fine.

• 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: 22876913
• Report Number: 2027111-2025-00707
• Device Sequence Number: 5752873
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• 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): 01/15/2026

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: 1543765
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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