MAUDE Adverse Event Report: GE HEALTHCARE TEE 4 D ULTRASOUND PROBE 6VT-D

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Esophagus (2399)

Event Date 04/02/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 a tee was performed in the cath lab.The physician later stated that he noticed the tee probe was broken.The provider stated that when you steer up it went past 90 degrees, should only steer to 90 degrees.The outcome of a tear was not discovered until (b)(6) 2018 after the patient developed black tarry stools and an egd was performed.During the egd the physician found in the distal esophagus a rather large tear approximately 2.5 cm at the ge junction with a large adherent clot and small amount of oozing.Area was injected with epinephrine, the clot was slowly removed under suction.The 3 resolution endo clips were used to appropriate the edges of the tear over these 2 areas as well as closing the proximal end of the tear as well.Patient required blood transfusion, 3 units given.The 4d tee probe had been sent out for repair prior to discovering the adverse outcome to this patient.

• Brand Name: TEE 4 D ULTRASOUND PROBE 6VT-D
• Type of Device: TEE 4 D ULTRASOUND PROBE 6VT-D
• Manufacturer (Section D): GE HEALTHCARE; wauwatosa WI
• MDR Report Key: 7451874
• MDR Text Key: 106409277
• Report Number: 7451874
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Distributor Facility Aware Date: 04/06/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• 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): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 107