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

Model Number	CD005
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	05/04/2026
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: lap chole.Event description: we received a call from a customer at [name].She advised when surgeon was using product item cd005 when deployed a piece fell into the patient's abdomen.Information provided by [name] via email thread on (b)(6) 2026: deploying bag, a piece fell off inside abdomen., which had to be retrieved.Information provided by [name] via email thread on (b)(6) 2026: i have a complaint below about another white piece of the ripstop 10mm bag coming off into the patient.This is the 2nd time this has happened in 2 months for [name].I will be going there tomorrow to help facilitate the return and see if there may be a deployment issue on their end.The customer mentioned they spoke with customer service yesterday and gave all pertinent information.Information provided by [name] via email on (b)(6) 2026: there was no spillage out of the bag.The bag did not break into pieces and did not completely fall off of the metal supports.No, the supports did not remain inside the introducer tube.The white plastic piece in shaft came out and into the patient when doing final deployment.No, the actuator was not pushed forward, retracted, and then deployed again, it was used as a one-time use ¿ deployed & retracted.Intervention: case went on as usual.Piece was retrieved.Patient status: no clinical impact.The patient is fine.

• Brand Name: INZII RIPSTOP REDEPLOYABLE 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: 25414046
• Report Number: 2027111-2026-00590
• Device Sequence Number: 12222442
• Product Code: GCJ
• UDI-Device Identifier: 00607915145521
• UDI-Public: (01)00607915145521
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K232880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: CD005
• Device Catalogue Number: 101475688
• Device Lot Number: 1573500
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 12/22/2025
• 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
• Patient Sex: Unknown