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

Model Number	C2A12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy, bso case.Event description: feedback submission - complaint notification - 7438.During this hysterectomy, bso case the patient's left fallopian tube was caught behind the inner ring of the alexis.The surgeon did not perform a tissue sweep after inserting the alexis and did not become aware that the left fallopian tube was trapped behind the inner ring until toward the end of the procedure.The surgeon had already mobilized the uterus and right fallopian tube when he noticed the left tube was trapped when looking for that structure.A very small portion of the left tube was sticking out beyond the ring, and the surgeon attempted to grab the tube with his laparoscopic grasper, but this was unsuccessful.The surgeon then tried to reposition the entire platform in multiple directions while still grasping the tube under tension to attempt to free it, which was also unsuccessful.The clinical education specialist present at the case suggested removing the gelseal cap and performing a finger sweep to free the tube, but this was unsuccessful.The ces also recommended unrolling the alexis to relieve some tension, but the surgeon decided instead to completely remove the v-path device and remove the left fallopian tube vaginally.The patient had a large anterior fibroid, and the surgeon commented that they would have been able to complete the case entirely vaginally due to the fibroid.Additional information obtained from (b)(6) (clinical development) via email on 12feb2025 (entered by (b)(6)): the event date was (b)(6) 2025.Intervention: completely remove the v-path device and remove the left fallopian tube vaginally.Patient status: no issues.Doing fine.
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
Correction: b5.Redacting names d10.Adding concomitant device from event description.
Event or Problem Description
Procedure performed: hysterectomy, bso case.Event description: feedback submission - complaint notification - (b)(4).During this hysterectomy, bso case the patient's left fallopian tube was caught behind the inner ring of the alexis.The surgeon did not perform a tissue sweep after inserting the alexis and did not become aware that the left fallopian tube was trapped behind the inner ring until toward the end of the procedure.The surgeon had already mobilized the uterus and right fallopian tube when he noticed the left tube was trapped when looking for that structure.A very small portion of the left tube was sticking out beyond the ring, and the surgeon attempted to grab the tube with his laparoscopic grasper, but this was unsuccessful.The surgeon then tried to reposition the entire platform in multiple directions while still grasping the tube under tension to attempt to free it, which was also unsuccessful.The clinical education specialist present at the case suggested removing the gelseal cap and performing a finger sweep to free the tube, but this was unsuccessful.The ces also recommended unrolling the alexis to relieve some tension, but the surgeon decided instead to completely remove the v-path device and remove the left fallopian tube vaginally.The patient had a large anterior fibroid, and the surgeon commented that they would have been able to complete the case entirely vaginally due to the fibroid.Additional information obtained from [name] (clinical development) via email on 12feb2025: the event date was 03feb2025.Intervention: completely remove the v-path device and remove the left fallopian tube vaginally patient status: no issues.Doing fine.
Event or Problem Description
Procedure performed: hysterectomy, bso case.Event description: during this hysterectomy, bso case the patient's left fallopian tube was caught behind the inner ring of the alexis.The surgeon did not perform a tissue sweep after inserting the alexis and did not become aware that the left fallopian tube was trapped behind the inner ring until toward the end of the procedure.The surgeon had already mobilized the uterus and right fallopian tube when he noticed the left tube was trapped when looking for that structure.A very small portion of the left tube was sticking out beyond the ring, and the surgeon attempted to grab the tube with his laparoscopic grasper, but this was unsuccessful.The surgeon then tried to reposition the entire platform in multiple directions while still grasping the tube under tension to attempt to free it, which was also unsuccessful.The clinical education specialist present at the case suggested removing the gelseal cap and performing a finger sweep to free the tube, but this was unsuccessful.The ces also recommended unrolling the alexis to relieve some tension, but the surgeon decided instead to completely remove the v-path device and remove the left fallopian tube vaginally.The patient had a large anterior fibroid, and the surgeon commented that they would have been able to complete the case entirely vaginally due to the fibroid.Additional information obtained from [name] (clinical development) via email on 12feb2025: the event date was 03feb2025.Intervention: completely remove the v-path device and remove the left fallopian tube vaginally.Patient status: no issues.Doing fine.
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 relevant documentations 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: 21554461
• Report Number: 2027111-2025-00404
• Device Sequence Number: 8164729
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,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: 02/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/10/2025; 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: LAPAROSCOPIC GRASPER.
• Patient Sex: Unknown