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

Model Number	C2A15
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/23/2025
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: v-notes adnexal surgery event description: during a v-notes adnexal surgery, the introducer was inserted through the pouch of douglas and the ring was deployed.At that time, bleeding was observed on both sides of the rectal mesentery.According to the physician, the bleeding on the left side may have been due to a laceration, which was sutured for hemostasis.It was considered that the bleeding may have been caused by tension applied to the rectal mesentery during deployment of the ring from the introducer, resulting in tissue injury.No patient injury or illness associated with this event.Replaced with a hospital inventory, and the procedure was completed.The investigation report has been not requested by the hospital.This event unit will not be returned.Additional information received 16mar2026 (from sales rep) regarding the case: preoperative evaluation the patient was evaluated, and it was confirmed that the pouch of douglas was not obliterated.Anatomical considerations there were no specific anatomical challenges reported that would have made the colpotomy particularly difficult (such as adhesions, unusual depth, or angle).Colpotomy technique and difficulty regarding the creation of the colpotomy: ¿ opening the pouch of douglas required slightly more time than usual.¿ the patient had a somewhat thicker fat layer around the rectum.Device insertion ¿ the device was inserted using the standard technique.¿ there was no resistance or particular difficulty during insertion.¿ the device was positioned slightly to the right of the midline (patient¿s left side).Cause of the bleeding on the left side the surgeon commented that the bleeding might have been caused by a tear.Based on the follow-up discussion, it is believed that the tear was likely caused by the device, possibly during ring deployment.Intervention: kept using the event unit and the procedure was completed.Patient status: bleeding was observed on both sides of the rectal mesentery.

• 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: 24795498
• Report Number: 2027111-2026-00479
• Device Sequence Number: 9727302
• Product Code: HEW
• UDI-Device Identifier: 00607915138493
• UDI-Public: (01)00607915138493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2A15
• Device Catalogue Number: 101474671
• Device Lot Number: 1560070
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown