MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT PATH TRANSANAL ACCESS PLATFORM; ANOSCOPE AND ACCESSORIES

Model Number	CNB11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
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: tamis.Event description: hospital name: [name] "dr was insufflating", "gelpoint path was leaking from the access channel dr had to press the whole system against the skin and the gel against the access channel to prevent leaking no insufflation took place".Additional information received by field team on august 25, 2025 by email: please note that we did not see any duckbill falling.Neither inside nor outside the patient.Also, i don't think this was the problem, since we tried attaching the insufflation directly to the gel rather than the isb and trocar, it still leaked air.Intervention: continued with minimal vision.Patient status: good.
Event or Problem Description
Procedure performed: tamis.Event description: hospital name: [name]."dr was insufflating", "gelpoint path was leaking from the access channel dr had to press the whole system against the skin and the gel against the access channel to prevent leaking no insufflation took place".Additional information received by field team on august 25, 2025, by email: please note that we did not see any duckbill falling.Neither inside nor outside the patient.Also, i don't think this was the problem, since we tried attaching the insufflation directly to the gel rather than the isb and trocar, it still leaked air.Intervention: continued with minimal vision.Patient status: good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the duckbill, an internal rubber component of the sleeve, was fully dislodged from the sleeve.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.

• Brand Name: GELPOINT PATH TRANSANAL ACCESS PLATFORM
• Common Device Name: ANOSCOPE AND ACCESSORIES
• 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: 22946492
• Report Number: 2027111-2025-00735
• Device Sequence Number: 9151374
• Product Code: FER
• UDI-Device Identifier: 00607915137922
• UDI-Public: (01)00607915137922
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K171701
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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 Model Number: CNB11
• Device Catalogue Number: 101474659
• Device Lot Number: 1528040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2025
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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