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	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: right colectomy.Event description: when stretching the membrane to position the alexis, the internal ring (pink) detached from the membrane.Nothing on the patient.Additional information received from nca via email on 27may26: during a right colectomy, the retractor presented a problem: the transparent sheath had become detached from the rigid ring.Delay in the surgery.Stress for the surgeon and the teams.Additional costs for the hospital.Additional information received from applied medical representative via email on 01jun26: the ring detached from the membrane.No leak, broken device.It happened at the time of tightening the alexis.No damage on the gelseal cap.No instruments placed directly through the gel.The leak did not occur only when instrumentation was placed through the trocar.Only cngl2 instrumentation was used during the procedure.No component separate from the sleeve/trocar seal when leakage occurred.No component fall out or appear to be torn off.Additional information received from applied medical representative via email on 02jun26: the patient is doing very well.Type of intervention: device replacement patient status: patient is doing very well.
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.

• 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: 25412338
• Report Number: 2027111-2026-00589
• Device Sequence Number: 14913002
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• 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: CNGL2
• Device Catalogue Number: 101473941
• Device Lot Number: 1569307
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 09/24/2025
• 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