MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC Transducer X7-2t; ULTRASOUND

Model Number 989605414121

Device Problem Difficult to Insert (1316)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

A thorough inspection with functional and safety tests of the involved transducer was performed by the local philips service engineer.Proper functionality of the transducer was confirmed and the device remains at the customer site.Since a return of the transducer is not expected, no additional device analysis can be performed.

Event Description

A customer reported detecting a perforated esophagus after attempting to perform a transesophageal (tee) examination using an x7-2t model transducer with an epiq ultrasound system.The doctor could not properly insert the transducer down the patient¿s esophagus, so the procedure was aborted.The injury was noticed the next day, and the patient was transported to another facility for treatment.Further information regarding the patient condition post procedure was not disclosed and the device remains at the customer site.

• Brand Name: Transducer X7-2t
• 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: 8714545
• MDR Text Key: 148522579
• Report Number: 3019216-2019-00030
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 989605414121
• Device Lot Number: B2JH9W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 51