MAUDE Adverse Event Report: SYMPHION; INSUFFLATOR, HYSTEROSCOPE

Model Number 08714729863717

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abdominal Pain (1685)

Event Date 10/16/2017

Event Type  Injury  

Event Description

During a hysteroscopy, a submucosal myomectomy the symphion system was used.Pt presented to er with extreme pelvic and abdominal pain.Ct showed fluid in the abdomen.Surgeon stated the system malfunctioned or did not work as designed during the procedure.

• Brand Name: SYMPHION
• Type of Device: INSUFFLATOR, HYSTEROSCOPE
• MDR Report Key: 6986709
• MDR Text Key: 90688432
• Report Number: MW5073027
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 08714729863717
• Device Lot Number: 62984936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 99