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

Model Number KN100110

Device Problems Loss of or Failure to Bond (1068); Residue After Decontamination (2325)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

Because of an increase of incidence of enterobacter aerogenetic bacterial infections after heart surgery, the customer performed an investigation to determine root cause.The customer reported to ge the possible cause of the bacterial infections may result from intraoperative use of tee probes.Their investigation concluded they were following ge¿s manufacturer specifications for cleaning and disinfection, and further investigation of one of the probes also determined bacteria was present in a crack formed where adhesive is applied at the point where the bending tip is joined to the endoscope.Hospital found active micro-organisms on the probe after they reprocessed it.However, they did not find enterobacter bacteria.The probe was analyzed by ge and there were no punctures found via visual and electrical evaluation.The deflection cover and scan-head of the endoscope were not compromised.Loose potting was observed between the deflection cover and scan-head of the endoscope which may explain the presence of micro-organisms after reprocessing.The customer explained in writing that they will not provide patient information including quantity of patients affected nor outcomes.Both the customer and ge's investigations are ongoing, and a follow-up report will be supplied upon conclusion of the investigations.

Manufacturer Narrative

Ge's investigation has finished and concluded: the tristel trio wipes high-level disinfection reprocessing method, which the customer was using, is unsuited for use in the operating room scenario on transesophageal probes with visible endoscope wear and this limitation is not covered in the cleaning & disinfection information issued by ge with the initial sale of this probe.It is noted that information was according to the requirements of applicable standards and therefore correct at the time, but through the knowledge acquired through this investigation it is now considered incomplete.

• 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: 6949422
• MDR Text Key: 89348022
• Report Number: 9610482-2017-00006
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KN100110
• Device Lot Number: 203598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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