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

Model Number	CNB10
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	03/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being 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: the doctor informed me couple of days after his surgery that while performing a tamis case using the gelpoint path early this week; which he used several times before; one of the trocar¿s seal was loose and part of it went inside the patient.He detected the piece missing and removed it and replaced the trocar with another one and continued the surgery with no harm to the patient.He forgot to inform the nurses in time to keep all the components of the gelpoint path or at least the defected trocar, so they discarded it directly after the surgery as per the usual protocol.Additional feedback received from the field team via email on (b)(6) 2026: the lot number: 1552944 is correct.The trocar¿s seal was the part that was loose and detached, which then entered inside the patient.Intervention: he was able to continue the case with the same item.Patient status: no harm to the patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: tamis.Event description: the doctor informed me couple of days after his surgery that while performing a tamis case using the gelpoint path early this week; which he used several times before; one of the trocar¿s seal was loose and part of it went inside the patient.He detected the piece missing and removed it and replaced the trocar with another one and continued the surgery with no harm to the patient.He forgot to inform the nurses in time to keep all the components of the gelpoint path or at least the defected trocar, so they discarded it directly after the surgery as per the usual protocol.Additional feedback received from the field team via email on march 15, 2026: the lot number: 1552944 is correct.The trocar¿s seal was the part that was loose and detached, which then entered inside the patient.Intervention: he was able to continue the case with the same item.Patient status: no harm to the patient.

• 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: 24793961
• Report Number: 2027111-2026-00478
• Device Sequence Number: 8805846
• Product Code: FER
• UDI-Device Identifier: 00607915137915
• UDI-Public: (01)00607915137915
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 04/23/2026

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: CNB10
• Device Catalogue Number: 101474658
• Device Lot Number: 1552944
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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