MAUDE Adverse Event Report: PHILIPS ULTRASOUND PEDIATRIC TEE BROADBAND SECTOR ARRAY; TRANSESOPHAGEAL PROBE

Model Number S7-3T

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2015

Event Type  malfunction  

Event Description

A patient with left ventricular dysfunction was scheduled for transesophageal echocardiogram (tee) in echo lab.Cardiologist was unable to intubate the esophagus after multiple attempts.Cardiologist had difficulty placing the adult tee probe and decided to use a pediatric tee probe which is a little smaller.While inserting the pediatric tee probe, it became lodged in the patient's throat.Gi physician assisted the cardiologist with removal of the pediatric tee probe.Patient tolerated this without any post complaints or issues.Patient went home shortly after the procedure without complaints.Hospital biotech staff evaluated the pediatric tee probe following the incident.They discovered that the steering mechanism of the probe is not operable.Probe was taken out of service and sent to manufacturer for evaluation.The directional function of the device was tested prior to use.When the device became lodged in the patient's throat, the directional function would not operate.Manufacturer response for transesophageal probe, phillips ultrasonic transducer (pediatrics tee probe) (per site reporter): phillips healthcare north america will investigate the malfunction.

• Brand Name: PEDIATRIC TEE BROADBAND SECTOR ARRAY
• Type of Device: TRANSESOPHAGEAL PROBE
• Manufacturer (Section D): PHILIPS ULTRASOUND; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5359780
• MDR Text Key: 35630159
• Report Number: 5359780
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2016

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?: No
• Device Operator: Physician
• Device Model Number: S7-3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 61 YR
• Patient Weight: 51