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

Model Number	CNGL2
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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: additional information received from applied medical representative via email on 09jan2026: during the case, the black flange came out of one of the purple sleeves found as part of the device (which is supposed to be fixed in situ).Device not replaced.Consultant put his finger over the port to prevent the gas from escaping and completed the case.Intervention: device not replaced.Consultant put his finger over the port to prevent the gas from escaping and completed the case.Patient status: fine/no issues or impact on patient.
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: 24180277
• Report Number: 2027111-2026-00338
• Device Sequence Number: 10149496
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 1555131
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR 5MM LAPAROSCOPIC INSTRUMENTS.; COMPETITOR LAPAROSCOPIC HANDPIECE.
• Patient Sex: Unknown