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	04/27/2026
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: laparoscopic supracervical hysterectomy.Event description: the plastic tore off the ring losing pressure and a second product was opened.They noticed it right away upon insufflating the abdomen.Additional information provided by company representative on 05may2026: it was not a robotic case.Additional information provided by company representative on 08may2026: the leakage occurred at the beginning of the procedure.They believe the leakage occurred in between the sheath and ring where it was disconnected.The leak did not occur only when instrumentation was placed through the trocar lap instruments were used during the procedure, but did not use as they did not gain pneumo with defective disconnection of sheath from ring.No, they did not observe a component separate from the sleeve/trocar seal when leakage occurred.No, the surgeon did not attempt to resolve the leakage as it was clearly disconnected 15 pressure and high flow.Unknown whether there are any damages on the gelseal cap pictures not available, was redbagged this was not a robotic procedure unknown at what point did the sheath separation occur (during insertion, mid-procedure, during removal), noticed when insufflated unknown if the sheath detached from white or purple inner ring.Type of intervention: a second product was opened.Patient status: no injury indicated.

• 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: 25191854
• Report Number: 2027111-2026-00562
• Device Sequence Number: 10385271
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/15/2026
• 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
• Patient Sex: Unknown