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 Type  malfunction  

Event Description

Procedure performed: hysterectomy bso.Event description: complaint created based off feedback# (b)(4).Case (b)(6) 2024.In order to create the anterior colpotomy, the surgeon inverted the uterus.Once out of position, the uterus remained inverted and was posterior to the alexis (between the alexis and posterior peritoneum) upon insertion.They attempted to insert the alexis twice and noted the entrapped uterine tissue upon visual inspection on both attempts (after rolling down the outer ring, attaching the gelseal cap, and inserting their lap scope/instruments).They did complete a finger sweep prior to rolling alexis outer ring on both attempts, but the entrapped tissue was noted on visual inspection.After the two insertion attempts, they converted to complete a vaginal hyst using voyant.After removing the uterus, the alexis was reinserted successfully to do a vnotes bso.After the case, the surgeon agreed to not invert the uterus in the future.No adverse outcomes were reported.Summary: inverted uterine tissue entrapment, difficulty inserting alexis due to difficult patient anatomy (inverted uterus), conversion to tvh due to patient anatomy, successful vnotes post-hyst intervention: after the two insertion attempts, they converted to complete a vaginal hyst using voyant.After removing the uterus, the alexis was reinserted successfully to do a vnotes bso.Patient status: no adverse outcomes were reported.

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.

• 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: 18813289
• MDR Text Key: 337633288
• Report Number: 2027111-2024-00424
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• 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
• Treatment: VOYANT.