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

Model Number	C2A12
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes.Event description: i wanted to let you all know of a vnotes case on (b)(6) 2026 with dr.[name] at [hospital] where tissue entrapment occurred.Dr.[name] identified that tissue was trapped after placing the v-path.The surgeon decided to free the entrapped tissue while the v-path was placed using smooth bowel grasper manipulation and digital manipulation with her hands between the inner ring and the pelvic sidewall.Once the entrapped tissue was freed, dr.[name] continued and completed the case via vnotes.No patient injury was reported.We are reporting this as a complaint because entrapment occurred and pulling entrapped tissue from under the retracted alexis has the potential to cause tissue damage.Additional information provided by [company representative] via email on 30apr2026: tissue was trapped between the inner ring and the pelvic sidewalls.There were no challenges with the patient's anatomy, but the v-path was placed post-hysterectomy.Type of intervention: once the entrapped tissue was freed, dr.[name] continued and completed the case via vnotes.Patient status: no clinical impact.The patient is fine.
Additional Manufacturer Narrative
The event unit is not being returned for evaluation, and no lot number has been provided to applied medical.A follow up report will be provided upon completion of the investigation.

• 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: 25062314
• Report Number: 2027111-2026-00542
• Device Sequence Number: 10131938
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: C2A12
• Device Catalogue Number: 101474657
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/01/2026
• 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