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

Model Number	C2A12
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy and salpingectomy.Event description: feedback 7169 during this hysterectomy, salpingectomy case the patient's left fallopian tube was caught behind the inner alexis ring.The surgeon did not perform a tissue sweep after inserting the device to ensure there was no tissue entrapment.The surgeon also did not confirm the location of the fallopian tubes with a scope prior to starting resection, as they did not know the left fallopian tube was entrapped until after the uterus and right fallopian tube had been removed.The surgeon then removed the v-path device to free the left fallopian tube and then proceeded to remove it vaginally.The left fallopian tube was hanging very low, and this was likely the reason it was caught behind the ring, but it did not cause any problems throughout the procedure.Additional information obtained from [name] on 27nov2024 no other devices were used.I don't have the lot number and the product is not being returned.The surgeon didn't think there was anything wrong with the product during this procedure.The patient's fallopian tube was just lower than normal.No closing report was requested and there was no patient harm.Additional information obtained from [name] on 02dec2024 the device was discarded.Intervention: the surgeon removed the v-path device to free the left fallopian tube.Patient status: no patient injury.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.However, based on the description of the event, applied medical was able to confirm the customer's experience of tissue entrapment.Based on the description of the event, it is possible that the tissue entrapment was caused by a failure in performing an adequate finger sweep to check for entrapped tissue.The instructions for use (ifu) state: "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 relevant documentations were identified.
Event or Problem Description
Procedure performed: hysterectomy and salpingectomy.Event description: during this hysterectomy, salpingectomy case the patient's left fallopian tube was caught behind the inner alexis ring.The surgeon did not perform a tissue sweep after inserting the device to ensure there was no tissue entrapment.The surgeon also did not confirm the location of the fallopian tubes with a scope prior to starting resection, as they did not know the left fallopian tube was entrapped until after the uterus and right fallopian tube had been removed.The surgeon then removed the v-path device to free the left fallopian tube and then proceeded to remove it vaginally.The left fallopian tube was hanging very low, and this was likely the reason it was caught behind the ring, but it did not cause any problems throughout the procedure.Additional information obtained from [name] on 27nov2024, no other devices were used.I don't have the lot number and the product is not being returned.The surgeon didn't think there was anything wrong with the product during this procedure.The patient's fallopian tube was just lower than normal.No closing report was requested and there was no patient harm.Additional information obtained from [name] on 02dec2024, the device was discarded.Intervention: the surgeon removed the v-path device to free the left fallopian tube.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: 20897403
• Report Number: 2027111-2024-00947
• Device Sequence Number: 5052428
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/09/2025

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: 11/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 05/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE.
• Patient Sex: Unknown