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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned for evaluation, and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Date of event: unknown procedure performed: robotic prostate.Event description: information provided by [account rep] via phone call on (b)(6) 2026: during a prostate surgery the sheath split inside the patient leading to leaked pneumoperitoneum.Information provided by [applied medical team member] via teams message on 09mar2026: hi [name]! an applied account rep, [name], has heard that there is a complaint regarding a cngl2 device at [user facility].I was wondering if you have any information regarding this event? [name]: i do not have any information regarding this event.I have been trying to follow up with the account regarding this, however i have not heard anything back information provided by [applied medical team member] via email on 25mar2026: the lot number is unknown as the device was not saved.The event date cannot be confirmed and it happened a few weeks ago.The procedure is a robotic prostate.A new gelpoint was opened and replaced the alexis to complete the procedure.The robotic trocar/camera and 10mm gelpoint sleeve were used along with the cngl2.The sheath separated from the outer ring.No instruments were used with the alexis during placement.There are no damages to the gelseal cap.There was no patient injury.Intervention: a new gelpoint was opened and replaced the alexis patient status: no clinical impact.The patient is fine.

• 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: 24737394
• Report Number: 2027111-2026-00466
• Device Sequence Number: 13309748
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 10MM GELPOINT SLEEVE; ROBOTIC TROCAR/CAMERA
• Patient Sex: Unknown