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	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lash.Event description: i attended the operation.Device was placed correctly - it's possible that when installing the alexis, the sheath was turned inside out one rotation too many.It seemed like a lot of pressure.Patient was in trendelenburg position, laparoscope was inserted caudad.The sheath came loose from the inner purple ring during the procedure.When the alexis was being removed, a loop of intestine became entangled around the inner purple ring(there was no sheath at this point) so the ring had to be cut.It occurred no visible or noticeable harm to the patient.The surgery could continue, but it was much more difficult to resect the specimen.Additional information received from applied medical representative via email on 29may26: i already answered most of the questions in the complaint form attached.The gelpoint been in use before the sheath detachment from the purple inner ring was observed roughly 30 minutes in the procedure.It entrapped after cutting the purple ring.The surgeon performed a tissue sweep before and after rolling the alexis down.Type of intervention: the surgery could continue, but it was much more difficult to resect the specimen.Patient status: no patient injury reported.
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: 25417105
• Report Number: 2027111-2026-00591
• Device Sequence Number: 20274674
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• 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: 1573312
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 12/02/2025
• 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: LAPAROSCOPE; LAPAROSCOPIC INSTRUMENTS
• Patient Sex: Unknown