MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; ULTRASOUND

Model Number 989605414121

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

Manufacturer Narrative

No product return is anticipated, therefore, no device evaluation can be performed.The transducer involved in the event could not be identified and no malfunction of the transducer was reported or asserted.

Event Description

A patient sustained damage to the esophagus during a transesophageal echocardiography (tee) examination using an x7-2t model transducer.The customer reported the damage to the esophagus was caused by an improper adjustment of the probe tip during extraction.Additional medical intervention was required to treat the patient¿s injury.The transducer involved in the event could not be identified and no malfunction of the transducer was reported or asserted.

• Type of Device: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 7341251
• MDR Text Key: 102489778
• Report Number: 3019216-2018-00018
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 989605414121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention