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

Model Number	CNGL3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic sigmoidectomy.Event description: [(b)(6)]."port inserted but not locked".Additional information received by distributor on (b)(6) 2025 via email: " it was stated that the problem was related to the separation of the gel seal cover." additional information received by distributor on (b)(6) 2025 via email: " it happened in the beginning of the procedure.No, the lever wasn't broken the cap was placed on alexis properly.They kept running procedure anyway it was everything was where they were supposed to be, the lever just didn't lock up." confirmed on (b)(6) 2025: event unit received had a torn sheath additional information received by distributor on (b)(6) 2025 via email: confirmed by account to be the correct unit for this complaint.No information was available as to the incident surrounding the sheath tear and the tear was not mentioned in the original product complaint.Intervention: the device was used until the end of the operation.Patient status: no clinical impact on the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.Engineering observed the (b)(6) sheath was torn.Based on the condition of the returned unit, it is likely that a sharp object or instrument came in contact with the sheath, resulting in a hole or tear that further propagated due to the stress experienced by the sheath.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable due to the sheath tear.
Event or Problem Description
Procedure performed: laparoscopic sigmoidectomy.Event description: [hospital name]."port inserted but not locked".Additional information received by distributor on (b)(6) 2025 via email: " it was stated that the problem was related to the separation of the gel seal cover." additional information received by distributor on (b)(6) 2025 via email: " it happened in the beginning of the procedure.No, the lever wasn't broken.The cap was placed on alexis properly.They kept running procedure anyway.It was everything was where they were supposed to be, the lever just didn't lock up." confirmed on (b)(6) 2025: event unit received had a torn sheath.Additional information received by distributor on 18 april 2025 via email: confirmed by account to be the correct unit for this complaint.No information was available as to the incident surrounding the sheath tear and the tear was not mentioned in the original product complaint.Intervention: the device was used until the end of the operation.Patient status: no clinical impact on the patient.

• Brand Name: GELPOINT® MINI 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: 21887082
• Report Number: 2027111-2025-00487
• Device Sequence Number: 3530555
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K191866
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Expiration Date: 09/12/2026
• Device Model Number: CNGL3
• Device Catalogue Number: 101473942
• Device Lot Number: 1503551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: EB215.
• Patient Sex: Unknown