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

Model Number	C2A12
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is 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.
Event or Problem Description
Procedure performed: hysterectomy, bso.Event description: this was a hysterectomy, bso case that was converted to a traditional vaginal approach.The patient had significant prolapse and the surgeon struggled to create the anterior colpotomy as well as seat the alexis ring.The surgeon decided to remove the uterus vaginally and complete the bso portion of the procedure via vnotes.Upon inserting the alexis, the inner ring caught the patient's left ovary, and it was stuck under the ring.The surgeon had to fish out the left ovary from under the alexis sheath.The surgeon did not perform a tissue sweep after inserting the inner ring of the alexis but did perform a visual inspection after placing the gelseal cap and visualized the ovary being caught.The surgeon was able to remove it and complete the case without injury to the patient.The case was successfully completed via vnotes.Additional information obtained from [name] via email on 31jan2025: the event date for this case was 12/17/24.Additional information obtained from [account manager] via phone call on (b)(6) 2025: there was no injury to the patient.The patient's anatomy did not pose any challenges while placing the alexis.The doctor is satisfied with using the devices.The doctor does not believe that the device malfunctioned.The account does not want credit or replacement.The account managers reported the case as a precautionary.The lot number is unknown, and the device was discarded by the hospital.Intervention: the surgeon was able to remove it and complete the case without injury to the patient.The case was successfully completed via vnotes.Patient status: the surgeon was able to remove it and complete the case without injury to the patient.
Event or Problem Description
Procedure performed: hysterectomy, bso.Event description: this was a hysterectomy, bso case that was converted to a traditional vaginal approach.The patient had significant prolapse and the surgeon struggled to create the anterior colpotomy as well as seat the alexis ring.The surgeon decided to remove the uterus vaginally and complete the bso portion of the procedure via vnotes.Upon inserting the alexis, the inner ring caught the patient's left ovary, and it was stuck under the ring.The surgeon had to fish out the left ovary from under the alexis sheath.The surgeon did not perform a tissue sweep after inserting the inner ring of the alexis but did perform a visual inspection after placing the gelseal cap and visualized the ovary being caught.The surgeon was able to remove it and complete the case without injury to the patient.The case was successfully completed via vnotes.Additional information obtained from [name] via email on 31jan2025: the event date for this case was 12/17/24.Additional information obtained from [account manager] via phone call on 05feb2025: there was no injury to the patient.The patient's anatomy did not pose any challenges while placing the alexis.The doctor is satisfied with using the devices.The doctor does not believe that the device malfunctioned.The account does not want credit or replacement.The account managers reported the case as a precautionary.The lot number is unknown, and the device was discarded by the hospital.Intervention: the surgeon was able to remove it and complete the case without injury to the patient.The case was successfully completed via vnotes.Patient status: the surgeon was able to remove it and complete the case without injury to the patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, the customer¿s experience of tissue entrapment was confirmed based on the event description.Based on the description of the event, it is likely that the reported event was caused by user error.The instructions for use (ifu) states, "before retraction of the outer ring, sweep area with fingers to ensure tissue is not trapped between the inner ring and peritoneum." applied medical has performed a historical trend analysis and review of production records and no trends were identified.

• 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: 21333927
• Report Number: 2027111-2025-00348
• Device Sequence Number: 3772315
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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