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

Model Number KN100110

Device Problems Failure to Disinfect (1175); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Ge has finished it's investigation of this issue with the customer.It was agreed that the customer had not properly followed instructions for cleaning and disinfecting the probe.The proper instructions for cleaning and disinfection of the probe were reviewed with the customer.The contaminated probes were removed from use immediately when the issue was found by the customer.With new probes and proper cleaning and disinfection it has been confirmed there were no more patient infections observed.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

Customer reported to (b)(6) authorities an issue with te probes causing several patient contaminations with e.Coli and pseudomonas microbes.The (b)(6) authorities in turn notified ge.

• Brand Name: 6VT-D PROBE
• Type of Device: TRANSESOPHAGEAL ULTRASOUND PROBE
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten ; NO
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2138; wauwatosa, WI
• MDR Report Key: 6225566
• MDR Text Key: 63957745
• Report Number: 9610482-2017-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K131514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• 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: 203319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other