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	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: tamis.Event description: [hospital].This is a complaint from the hospital: after the forceps was passing the sleeve, the sleeve flange came off and it fell into the abdominal cavity.No patient injury or illness associated with this event.The fragment was collected and procedure was completed.The investigation report has been requested by the hospital.This event unit will be returned.Intervention: the fragment was collected, and procedure was completed.Patient status: no patient injury or illness associated with this event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a dislodged shield.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument that was inserted or removed through the seal subassembly in a non-axial manner.The instructions for use (ifu) states, ¿all instruments should be centered axially when inserted through the sleeve¿s seal to avoid material particulation." applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: tamis.Event description: [hospital].This is a complaint from the hospital; after the forceps was passing the sleeve, the sleeve flange came off and it fell into the abdominal cavity.No patient injury or illness associated with this event.The fragment was collected and procedure was completed.The investigation report has been requested by the hospital.This event unit will be returned.Intervention: the fragment was collected, and procedure was completed.Patient status: no patient injury or illness associated with this event.

• 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: 22097281
• Report Number: 2027111-2025-00554
• Device Sequence Number: 7356969
• Product Code: FER
• UDI-Device Identifier: 00607915137922
• UDI-Public: (01)00607915137922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/08/2025

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: 1533522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FOECEPS.
• Patient Sex: Unknown