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

Model Number 6VT-D PROBE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Tissue Damage (2104); Perforation of Esophagus (2399)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a female patient received an esophageal tear during a tee procedure with a 6vt-d probe.The tear was in approximately 1/3 of the esophagus and surgery was required to repair the injury.The customer's report has said a right thoracotomy was required possibly due to fluid on lungs.Additionally, it was not recorded within the report whether or not the patient had a pre-existing condition.Ge's investigation is ongoing.

Manufacturer Narrative

Ge's investigation has completed.The customer evaluated the probe and they do not allege that the te probe is defective.The customer would not supply test results and ge was allowed onsite to visually inspect and run a bite hole test on the probe.The probe was visually ok and it passed the bite hole test.The customer would not release the probe to ge for further evaluation and they would not supply additional event information after multiple attempts to retrieve it.Therefore, the conclusion ge can draw is that the te probe did not malfunction, and it is inconclusive that the probe caused the adverse event.Therefore, ge believes the most likely cause of the adverse event is known inherent risk of te procedures.Ge further evaluated the complaint file for adverse trends and none were found.No further actions are planned at this time.

• Brand Name: 6VT-D PROBE
• Type of Device: 6VT-D ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• MDR Report Key: 8828533
• MDR Text Key: 152493516
• Report Number: 9610482-2019-00003
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6VT-D PROBE
• Device Catalogue Number: H45581BJ
• Device Lot Number: 210877
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention