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

Model Number	CD003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.This report is to follow-up medwatch uf/importer report# (b)(4).
Event or Problem Description
Procedure performed: re-exploration surgery.Event description: the complaint was generated from medsun uf/importer report # (b)(4) received on 23sep2025.Surgery performed [date redacted] - removal of gastric foreign body.Re-exploration surgery performed [date redacted] - 6 days after surgery - discovery of 5 mm endocatch bag in the abdomen missing black string.Intervention: removal of gastric foreign body, re-exploration surgery performed.Patient status: removal of gastric foreign body, re-exploration surgery performed.
Additional Manufacturer Narrative
This medwatch report # 2027111- 2025-00818 was a medsun report # (b)(4).Following applied medical¿s submission of the initial report regarding medwatch report # 2027111- 2025-00818, applied medical determined that this medwatch report is for the same event that was previously captured in medwatch report # 2027111- 2025-00733.Therefore, medwatch report # 2027111- 2025-00818 is a duplicate of medwatch report # 2027111- 2025-00733.The result of the complainant¿s experience investigation has been documented under medwatch report # 2027111- 2025-00733.
Event or Problem Description
Procedure performed: re-exploration surgery.Event description: the complaint was generated from medsun uf/importer report (b)(4) received on 23sep2025 surgery performed [date redacted] - removal of gastric foreign body.Re-exploration surgery performed [date redacted] - 6 days after surgery - discovery of 5 mm endocatch bag in the abdomen missing black string.Intervention: removal of gastric foreign body, re-exploration surgery performed.Patient status: no patient injury.Removal of gastric foreign body, re-exploration surgery performed.

• 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: 23373428
• Report Number: 2027111-2025-00818
• Device Sequence Number: 8870538
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1551450
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 04/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Unknown