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

Model Number	CD001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: cholecistectomy.Event description: device used during endoscopic surgery for the removal of anatomical parts.Once the device was inserted into the patient, the gallbladder was encased in a bag.The gallbladder was secured.The bag was then closed using the correct method.At this point, a breakage of the end cap of the device was noticed.This final portion remained inside the device, but there was a risk that it could fall into the abdominal wall.Additional information received from applied medical representative via pcf form on (b)(6) 2025: during a laparoscopic cholecystectomy, the surgeon introduced the retrieval bag cd001 into the abdomen, bagged the gallbladder, closed the retrieval to pull it outside abdomen.While closing the bag she noticed that the green guide was fallen inside the bag (luckily didn't fall in the abdomen).The device was used as usual.Intervention: unknown.Patient status: patient is ok.
Event or Problem Description
Procedure performed: cholecistectomy.Event description: device used during endoscopic surgery for the removal of anatomical parts.Once the device was inserted into the patient, the gallbladder was encased in a bag.The gallbladder was secured.The bag was then closed using the correct method.At this point, a breakage of the end cap of the device was noticed.This final portion remained inside the device, but there was a risk that it could fall into the abdominal wall.Additional information received from applied medical representative via pcf form on 13aug25: during a laparoscopic cholecystectomy, the surgeon introduced the retrieval bag cd001 into the abdomen, bagged the gallbladder, closed the retrieval to pull it outside abdomen.While closing the bag she noticed that the green guide was fallen inside the bag (luckily didn't fall in the abdomen).The device was used as usual.Additional information received from applied medical representative via email on 01sep25: they just checked nothing had remained in the abdomen.No spillage out of bag opening.The guide bead was not pulled on with an instrument.The guide bag detached from the bag.The bag was damaged.The guide bead detached from the cord.No cord damage.Snap ring was attached.No pictures available.Intervention: they just checked nothing had remained in the abdomen.Patient status: patient is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the locking mechanism was detached from the bag.Based on the condition of the returned unit, it is likely that the reported event was caused by excess material during manufacturing causing an incomplete press of the clamp onto the locking mechanism during assembly.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.Correction: e1.Corrected title, first name, last name, and email.

• 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: 22883811
• Report Number: 2027111-2025-00708
• Device Sequence Number: 9604424
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Device Catalogue Number: 101473283
• Device Lot Number: 1547087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown