MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. S8-3T; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number S8-3T

Device Problems No Display/Image (1183); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

Prior to a cardiovascular surgery, a physician (md) and echocardiogram technician were performing a transesophageal echocardiography (tee) on a patient.They stood at the head of the bed and passed the tee probe into the esophagus.The tee was completed without difficulty and then the probe was left in for the procedure, which is a standard of care for cardiac surgery patients in the operation room (or).When the surgical repair was completed, it was noted that a clear image was not able to be obtained with the probe.In removing the scope, the tech noticed that a portion of the tip of the scope was missing.The tech stated that he knew that the scope was in good condition prior to inserting the probe because he looked at it when the lubricating jelly was applied.After this procedure was completed, a general surgeon performed an esophagoscopy to retrieve the foreign body.A chest and abdominal x-rays were completed as well.With all of these interventions, the foreign body could not be located.The physician (md) stated that they would monitor the patient for the passing of the foreign body.

• Brand Name: S8-3T
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everette hwy; bothell, WA 98021
• MDR Report Key: 4598462
• MDR Text Key: 5465052
• Report Number: 4598462
• Device Sequence Number: 1
• Product Code: IYO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: S8-3T
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.