MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT® ADVANCED ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CNGL2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: this is a complaint from the hospital; it was reported that the sheath and inner ring of the wound protector had come loose upon opening the package (though this may have happened after use? we plan to verify this as there is blood on them).No patient injury or illness associated with this event.Replaced with the hospital inventory, and the procedure was completed.The investigation report has not been requested by the hospital.This event unit will be returned.Additional information provided by personnel via email on 09jun2026: 1.During what step in the procedure did the malfunction occur? (placement, mid-procedure, removal).¿ if the time of occurrence is not known, at what point was the detachment noticed? the issue occurred during the procedure, specifically at the initial stage of insufflation.Details: after the start of surgery, a small initial incision was made, and the gelpoint wound protector was set.The gel cap was then attached, and insufflation was started.A leak in the insufflation was noticed, so the insufflation was temporarily stopped.When the gel cap was removed for inspection, a defect in the alexis device was discovered.The product was replaced with a new one, and the procedure was completed without further issues.2.How long had the gelpoint been in use before the sheath detachment from the purple inner ring was observed? the exact duration could not be confirmed, but based on the sequence above, it occurred almost immediately after use.3.Was the purple inner ring unrolled at any point before the procedure? the inner ring was deployed before use and inserted into the incision layer; however, no issue was observed at that time.4.Was this a robotic procedure? yes, it was a robotic surgery.Type of intervention: replaced with the hospital inventory, and the procedure was completed.Patient status: no patient injury or illness associated with this event.

• Brand Name: GELPOINT® ADVANCED ACCESS PLATFORM
• 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: 25451665
• Report Number: 2027111-2026-00593
• Device Sequence Number: 15630468
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: CNGL2
• Device Catalogue Number: 101473941
• Device Lot Number: 1567019
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 09/15/2025
• 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