MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D ROHS; TRANSESOPHAGEAL ULTRASOUND PROBE

Model Number KN100110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Esophagus (2399)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Udi not required.The 6vt-d probe was not returned to ge healthcare for repair.The probe was given to a third party and therefore ge is unable to evaluate the probe further.

Event Description

Ge healthcare received a copy of a medwatch report from a user facility where in was described patient underwent a tee in a cath lab and post-procedure the physician noted the 6vt-d probe was broken.The report alleges that the probe would steer past 90 degrees.The report says the patient developed black tarry stools and the egd was performed and the physician found in the distal esophagus a rather large tear, approximately 2.5 cm/2/5 cm at the ge junction with a large adherent clot and small amount of oozing.The area was injected with epinephrine, and the clot was slowly removed under suction.Three resolution endo clips were used to approximate the edges of the tear over these two areas as well as closing the proximal end of the tear.Patient required blood transfusion, three units given.

Manufacturer Narrative

Ge's investigation has completed.Multiple attempts to collect additional information were made and the customer has declined to provide further information.Therefore the actual root cause could not be found due to the lack of information supplied by the customer.Ge has concluded there is not enough data to support that the patient injury was caused by a probe malfunction, and the most likely cause of the injury was either a result of the insertion, excessive manipulation associated with imaging, or during the removal of the probe after the tee procedure.

• Brand Name: 6VT-D ROHS
• Type of Device: TRANSESOPHAGEAL ULTRASOUND PROBE
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten ; NO
• MDR Report Key: 7574475
• MDR Text Key: 110262512
• Report Number: 9610482-2018-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K141093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KN100110
• Device Lot Number: 204852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 106