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

Model Number	CD003
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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 upon the completion of the investigation.
Event or Problem Description
Procedure performed: prostatectomy.Event description: 3 cd003 broke 1st bag- would not close, string came out of bag, bag was dropped into patient.2nd bag- would not deploy 3rd bag- would not close, string came out of bag was dropped into the patient.Had to extend incision, because the bag, string and specimen were lost in the patient.Hospital requested all of those bags be pulled from the shelf, and for upcoming procedures.This includes at least 9 bags, there are more boxes downstairs as well, that supply dept has requested not be used.18 total bags need to be replaced.Robot inst, robot trocars, air seal applied medical grasper.Additional information provided by [name] on 10dec2025 per email: after receiving the email with the questions about the guide bead, i returned to the hospital to speak with the or staff and check the bags from the case.I had instructed the staff to save the defective bags to return to applied.Upon checking the biohazard bag where the items were placed, i found only the introducers; the specimen bags themselves, where the guide beads should have been attached were not present.Two of the introducers still had the strings attached; however, the strings were not looped, and therefore no beads were attached.I then asked the team that was in the room at the time, if they recalled removing the guide bead along with the bag.Neither the scrub tech nor the first assist recalled seeing or removing a bead.The surgeon, who was at the robot console during that portion of the procedure, was also unsure.The surgeon asked to find the trash from the case, to see if the beads could be found, to make sure they were not left in the patient.At that point, several hours had passed since the procedure.The or director attempted to locate the trash, but it had already been removed and was unavailable to confirm.During the discussion, one staff member placed an unused cd003 on a mini-c-arm to assess visibility.The bag appeared radiopaque, although this is not indicated in the ifu (picture is attached).Based on this, the surgeon stated he would take a bedside x-ray with the bag placed next to the patient, to see if the bead showed up in the abdomen.If he saw the beads he would go back in tomorrow.This evening, the surgeon texted to inform me that the sample bag placed next to the patient did not appear on x-ray.As a result, nothing was visualized on the patient imaging.Intervention: had to extend incision, because the bag, string and specimen were lost in the patient.Patient status: no patient injury.

• 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: 24012969
• Report Number: 2027111-2026-00310
• Device Sequence Number: 18477511
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1562538
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AIR SEAL APPLIED MEDICAL GRASPER.; ROBOT INST, ROBOT TROCARS.
• Patient Sex: Unknown