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

Model Number	CD004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: nephrectomy event description: when surgeon closed the bag, the drawstring snapped off, and bag reopened.Additional information received from applied medical representative via email on 05jun25: the rep was attending the case late afternoon on the day it occurred.The drawstring broke / snapped where it loops around the hook on the handle.It happened above the guide bead, the kidney did fall out the bag again, but dr opened another bag to secure the specimen.No fragments were found it was a clean "snapped" drawstring.When the drawstring broke where it loops around the hook on the handle, the bag including the string slid out of the barrel where the bag is rolled up in due to the size of the kidney.Intervention: opened another bag.Patient status: patient is fine.
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: nephrectomy.Event description: when surgeon closed the bag, the drawstring snapped off, and bag reopened.Additional information received from applied medical representative via email on 05jun2025: the rep was attending the case late afternoon on the day it occurred.The drawstring broke / snapped where it loops around the hook on the handle.It happened above the guide bead, the kidney did fall out the bag again, but dr opened another bag to secure the specimen.No fragments were found it was a clean "snapped" drawstring.When the drawstring broke where it loops around the hook on the handle, the bag including the string slid out of the barrel where the bag is rolled up in due to the size of the kidney.Intervention: opened another bag.Patient status: patient is fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cord loop and uncinched bag.It was observed that the ends of the cord loop were frayed.Based on the condition of the returned unit and the description of the event, it is possible that the cord was susceptible to breakage and fraying from the manufacturing process.It is also possible that the cord broke due to excessive tensions being applied to the cord during the bag removal.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was 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: 22302748
• Report Number: 2027111-2025-00599
• Device Sequence Number: 20837353
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 1538687
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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