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

Model Number KN100120

Device Problems Loss of or Failure to Bond (1068); Material Puncture/Hole (1504); 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.Model #/lot #: 203598, 206227, 208198.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.This information was supplied to ge and the investigation is ongoing.To date ge has been able to visit the customer and confirm proper cleaning and disinfection up until the facility found the bacteria on the probe and changed their process.At this point the hospital then cleaned the probes with a soak based reprocessing method, sekusept 2% for 15 minutes in the c-10 optima tea cleaning machine from (b)(6).This also failed to remove and kill the micro-organisms.It is not clear what enzymatic cleaning method, wipes or soak and what chemical, was used at this point since the c-10 does not include pre-cleaning.Additionally, ge confirmed the cracks under the adhesive which were discovered by the hospital are in the material covering the transition at both ends of the articulation section and they contained bacteria.This indicated that the adhesive was not well sealed and it is suspected that the reason for the ineffectiveness of the reprocessing by soak was that some of the micro-organisms had created a biofilm that was not penetrated by the disinfectant, thereby not all the bacteria were reached.A follow-up report will be supplied upon conclusion of the investigation.

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.

Manufacturer Narrative

(b)(4).Probe was received by ge.Customer took probe apart for their analysis/investigation so puncture testing could not be performed.Visual inspection indicates a puncture with fluid leakage into the probe.Indications from discussions with the customer are that they used the probe with the puncture and thus patient contamination most likely occurred.Based on discussions with the customer and documentation provided by the customer it is unclear whether or not the bite hole test failed or passed for the customer before they used the probe with the puncture in it.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.

• 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: 6803953
• MDR Text Key: 83023020
• Report Number: 9610482-2017-00005
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KN100120
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 07/13/2017
• Supplement Dates FDA Received: 10/13/2017; 12/22/2017
• 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