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

Model Number	CD001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation, and no lot number has been provided to applied medical.A follow up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni event description: event date is unknown.The bag tore during removal from the body.The customer did not specifically report this as a complaint.During an operating room visit, it was mentioned that our retrieval bags sometimes tear when removed from the body.We have taken note of this.Additional information received from applied medical representative via email on 04sep25: the notice about the bag tearing was posted more as a general comment than as a complaint.Because we were there for a different issue, we didn't pay too much attention to it.I understand that you need more information.The person who reported it is currently on vacation.I will follow up with her after her vacation.I will see when i can stop by and discuss this with her.So it may take a while.Intervention: ni patient status: no clinical impact to the patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: ni.Event description: event date is unknown.The bag tore during removal from the body.The customer did not specifically report this as a complaint.During an operating room visit, it was mentioned that our retrieval bags sometimes tear when removed from the body.We have taken note of this.Additional information received from applied medical representative via email on 04sep25: the notice about the bag tearing was posted more as a general comment than as a complaint.Because we were there for a different issue, we didn't pay too much attention to it.I understand that you need more information.The person who reported it is currently on vacation.I will follow up with her after her vacation.I will see when i can stop by and discuss this with her.So, it may take a while.Intervention: ni.Patient status: no clinical impact to the 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: 23101148
• Report Number: 2027111-2025-00770
• Device Sequence Number: 9346964
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: CD001
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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