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	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic hysterectomy.Event description: surgeon and staff noticed pneumo was leaking.Upon investigating, they found that the alexis sheath had slid off from the inner purple ring.The gelpoint was removed and a new gelpoint was placed.Additional information provided by [company rep] via email on 01apr2026: the gelpoint had been in use for about an hour before the sheath detachment from the purple ring was observed.The purple ring was not unrolled at any point before the procedure.The leakage occurred about an hour after placing the gelpoint ½ way through the procedure.Leaking occurred whether there was an instrument in the gel trocar sleeve or not.No component separated from the sleeve/trocar seal when leakage occurred.There are no damages to the gelseal cap.There were no instruments used with the alexis during placement.Instruments were used in the gel sleeves during the procedure and subsequently, passed through the alexis into the abdominal cavity.Additional information provided by [name] via voluntary user report [mw (b)(4)] on 09apr2026: the wound protector tore during the case resulting in loss of co2 pneumo.Wound protector was replaced and case proceeded without any patient harm.Rep aware and placing a complaint with applied medical.Intervention: the gelpoint was removed and a new gelpoint was placed.Patient status: no patient injury.The patient is fine.
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.This is a follow-up report to mw (b)(4).

• 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: 24904984
• Report Number: 2027111-2026-00494
• Device Sequence Number: 18417710
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 1562169
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 07/23/2025
• 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: LAPAROSCOPIC GRASPER.; ROBOTIC SCOPE.
• Patient Age: 53 YR
• Patient Sex: Female