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

Model Number	C2A12
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	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: ai translated: during surgery, the plastic tip of the gelpoint v-path device, reference (b)(4) from batch 1547987, disconnected from the platform.No serious consequences for the patient.Risk that the detached plastic tip could remain lodged in the patient's vagina.Intervention: ni patient status: no serious patient consequences.Risk that the detached plastic tip could remain lodged in the patient's vagina.
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.
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 documentations were identified.
Event or Problem Description
Procedure performed: ni.Event description: ai translated: during surgery, the plastic tip of the gelpoint v-path device, reference (b)(4) from batch 1547987, disconnected from the platform.No serious consequences for the patient.Risk that the detached plastic tip could remain lodged in the patient's vagina.Intervention: ni.Patient status: no serious patient consequences.Risk that the detached plastic tip could remain lodged in the patient's vagina.

• 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: 23513670
• Report Number: 2027111-2025-00852
• Device Sequence Number: 13250528
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: C2A12
• Device Catalogue Number: 101474456
• Device Lot Number: 1547987
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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