MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT V-PATH; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A15
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	02/13/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: vnotes.Event description: i was in a vnotes case today and i believe something plastic came out of the trocar for the attached model/lot number during the case.They were able to remove the plastic part without any issues but wanted to let you know.Additional information provided by [company rep] on 17feb2026 via email: no patient injury.Entire component fell out.Yes, pieces fell into the patient.No, the trocar did not slip during torquing.No, the sleeve was not repositioned.No, the product is not being returned.The procedure went well, the vpath was used and then disposed of.Neither replacement nor credit.Intervention: they were able to remove the plastic part without any issues.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the customer¿s experience of component dislodgement.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of instruments through the sleeve.The instructions for use (ifu) states, "all instruments should be centered axially when inserted through the sleeve seal." 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: vnotes event description: i was in a vnotes case today and i believe something plastic came out of the trocar for the attached model/lot number during the case.They were able to remove the plastic part without any issues but wanted to let you know.Additional information provided by [company rep] on 17feb2026 via email: no patient injury.Entire component fell out.Yes, pieces fell into the patient.No, the trocar did not slip during torquing.No, the sleeve was not repositioned.No, the product is not being returned.The procedure went well, the vpath was used and then disposed of.Neither replacement nor credit.Intervention: they were able to remove the plastic part without any issues.Patient status: no patient injury.

• Brand Name: GELPOINT V-PATH
• Common Device Name: CULDOSCOPE (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: 24565218
• Report Number: 2027111-2026-00432
• Device Sequence Number: 13094183
• Product Code: HEW
• UDI-Device Identifier: 00607915138493
• UDI-Public: (01)00607915138493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: C2A15
• Device Catalogue Number: 101474671
• Device Lot Number: 1562297
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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: TROCAR.
• Patient Sex: Unknown