MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5CM; CULDOSCOPE (AND ACCESSORIES)

Model Number C2A12

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

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 investigation.

Event Description

Procedure performed: hysterectomy w/bso.Event description: complaint created based off feedback 5886.Submitted 22sep2023.This was a planned vnotes hysterectomy with bso for a patient with stage 4 prolapse and history of ectopic pregnancy.It was converted to a traditional vaginal approach due to patient anatomy.Once the patient was under anesthesia, the uterus descended enough that the surgeon decided to remove it without the gelpoint v-path.He then inserted the v-path after the hysterectomy to take the tubes.The surgeon introduced with the correct technique and performed a finger sweep to check for entrapped tissue.Once inside the peritoneum under laparoscopic visualization, the surgeon discovered that the adnexa were trapped behind the inner ring of the alexis.The surgeon attributed this to the patient's prolapse and extensive adhesions from their prior ectopic pregnancy.The surgeon removed the v-path to take the adnexa, [name] noted that he enjoyed the visualization that he had when the port was in place and plans to do more vnotes cases in the future.Conversion to tvh due to patient anatomy product is not available for return.Additional information received on 11dec2023 via email from clinical development: it was confirmed there was no patient injury.Intervention: he surgeon removed the v-path to take the adnexa.Patient status: no patient injury occurred.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5CM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18329141
• MDR Text Key: 330956165
• Report Number: 2027111-2023-00854
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1