MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UC140P-AL5

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation and is pending investigation.The scope will be sent to an independent laboratory for microbiological testing and sterilization.The exact cause of the patient's outcome could not be conclusively determined at this time.As part of our investigation of this reported complaint, on august 25, 2015 an endoscope support specialist (ess) was dispatched to the user facility to assess their reprocessing practices.The ess observed the manual cleaning process by the user facility staff and found the following observations: devices were stacked on top of each other at the edge of the counter space, (in and out) of plastic bags waiting to be cleaned.There were unclean devices awaiting manual cleaning on average for longer than one hour.There was no policy in place at the user facility for pre-soaking the devices in detergent after extended use.The ess did not observe the technician brushing the valves in detergent water while completing manual cleaning.A dirty brush, sponge, and cloth were not disposed of after use and were left out next to the sink.There was no suctioning after brushing.The ess explained the infection risks associated with not completing those steps.The ess also demonstrated the manual reprocessing guidelines with the current staff.On august 31, 2015 the ess returned to the user facility to demonstrate the pre-cleaning procedure with or staff.The ess verified with staff, that all the channels were not being cleaned (suctioned/flushed) at bedside according to olympus' manual for reprocessing endoscopes.The ess went through necessary cleaning adapters and equipment needed for proper pre-cleaning.It was observed that the facility did not have an adequate number of cleaning adapters and equipment necessary in order to fulfill cleaning on an average daily work load.An olympus sales representative has been contacted to coordinate the ordering of the necessary material.The ess was reassured that only during severe occasions some scopes were stacked and delayed for more than an hour before being manually cleaned.The facility is in the process of acquiring more rigid containers in order to transport dirty scopes and to provide an extend soak in enzymatic detergent for scopes that have been delayed or heavily soiled.The facility is also in the process of acquiring additional staff to assist the current cleaning technician.A follow up visit to educate staff not present and the user facility's other locations will be scheduled for a future date.If additional and significant information becomes available at a later time these reports will be supplemented.

Event Description

Olympus was informed that a patient presented to the emergency room symptomatic and was treated for carbapenem-resistant enterobacteriaceae (cre) after undergoing an endoscopic ultrasound (eus) and diagnostic endoscopic retrograde cholangiopancreatography (ercp) procedure.It was reported that this caused the patient's scheduled surgery to be delayed.The user facility reported that the device had been reprocessed prior to the procedure and several times after.The device was later cultured by the facility and tested positive for cre.No further information was provided.Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the facility submitted a medsun report.

Manufacturer Narrative

This supplemental report is to provide the laboratory results, manufacture date and device evaluation results.Based on the microbiological testing conducted at an off-site laboratory, the scope tested positive for serratia marcescens/serratia ureiytica, stenotrophomonas maltophilia, achromobacter xylosoxidans, micrococcus luteus and rhodotorula mucilaginosa.The organisms were recovered from the instrument and suction channel.The scope was eto sterilized by an off-site laboratory before returning to olympus.A boroscope was used to examine the internal instrument channels of the scope and found no foreign material.Additionally, there were also no signs of foreign material found on the bending section cover, bending section cover glue, insertion tube, light guide tube and distal end cover of the device.The device passed a leak test.There were no abnormalities found with the scope.The cause of the patient's outcome could not be conclusively determined; however, insufficient reprocessing cannot be ruled out.The instruction manual warns users: "the medical literature reports incidents of patient cross contamination resulting from improper cleaning, disinfection or sterilization.It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies.".

• Brand Name: OLYMPUS ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5062216
• MDR Text Key: 25207672
• Report Number: 2951238-2015-00404
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

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: GF-UC140P-AL5
• Device Catalogue Number: GF-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention