MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION EVIS EXERA II DUODENOVIDEOSCOPE; DUODENOSCOPE

Model Number TJF-Q180V

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

Patient Problem Bacterial Infection (1735)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing practices.There were no deviations noted.In addition, an olympus field support engineer visited the user facility to evaluate the olympus oer-pros on site.The user facility was found to use olympus and non-olympus aers to reprocess their endoscopes.The user facility did not allege any deficiencies with their reprocessors but nonetheless, functionality testing was conducted.All olympus oer-pros performed normally without errors.The user facility was requested to return the suspect duodenoscope for further evaluation.The suspect device will be sent to an independent laboratory for further microbiology testing.The exact cause of the reported issue could not be conclusively determined at this time.For the five additional events, please reference following associated medwatch reports: 2951238-2016-00070, 2951238-2016-00071, 2951238-2016-00072, 2951238-2016-00073, and 2951238-2016-00075.

Event Description

Olympus was informed that following endoscopic retrograde cholangiopancreatography (ercp) procedures, six patients were infected with e.Coli, and two of the six patients have expired.The user facility has initiated culture testing, laboratory exams on the patients involved, and autopsy on the two patients that expired.The suspect duodenoscope tested negative for an in-house culture test.The user facility utilized an olympus automated endoscope reprocessor (aer) to reprocess their duodenoscopes.The device was taken out of service and will be returned to olympus for further evaluation.In addition, the user facility accepted an in-service to provide re-education of the reprocessing instructions.Report 5 of 6.

Manufacturer Narrative

On (b)(6) 2016, the facility informed olympus of two additional patients infected by e.Coli.The device referenced in this report was sent to an independent laboratory for microbiology testing.Sample fluid extracted from the suction channel recovered bacteria identified as stenotrophomonas maltophilia.The scope was then returned to olympus for evaluation.A visual examination of the device was performed and the following was noted; the bending section adhesive was whitish in color and had open gaps at each side of the bending section cover.The glue around the nozzle had signs of cracks and gaps.The interior glue for the c-body (distal end) had a large void and cracks.The insertion tube had multiple buckles throughout the entire length.The light guide lens was inspected under a microscope and brownish stains were noted internally.A boroscope was used to inspect the biopsy and suction channels.Brown stains and a scrape marks were found on the biopsy channel interior at 5.5 cm from the distal end.The suction channel had similar brown stains at various locations.Both channels had interior signs of damage which appear to be due to scrapes.The device was leak tested using a maintenance unit model mu-1, and we were able to confirm a leak by a continuous stream of bubbles emanating from the distal end of the device in the area where the c-body was missing glue.The device history record indicates the scope was purchased on 06/28/012 and last repaired by olympus on 08/23/2014.The device had a total of 791 uses.The device was serviced and returned to the facility.The facility has been informed of the investigation results.The reprocessing manual contains several warnings for proper inspection and testing including the following warning - "perform a leakage test on the endoscope after each pre-cleaning procedure, including confirmation that there is no leak from the forceps elevator, while raising and lowering the forceps elevator.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.".

Event Description

Olympus was informed that following endoscopic retrograde cholangiopancreatography (ercp) procedures, eight patients were infected with e.Coli, and two of the eight patients have expired.The user facility has initiated culture testing, laboratory exams on the patients involved, and autopsy on the two patients that expired.The suspect duodenoscope tested negative for an in-house culture test.The user facility utilized an olympus automated endoscope reprocessor (aer) to reprocess their duodenoscopes.The device was taken out of service and returned to olympus for further evaluation.In addition, the user facility accepted an in-service to provide re-education of the reprocessing instructions.Report 5 of 8.

Manufacturer Narrative

The purpose of this report is to provide additional information for the device evaluation of the facility's maintenance unit (mu-1).As an extension of the investigation the facility's maintenance unit, model# mu-1, and leakage tester, model# mb-155, were requested for evaluation in an effort to confirm proper functionality.The device evaluation into the performance of the accessory equipment was conducted as part of our investigation associated with the olympus tjf-q180v duodenoscope, serial number (b)(4).The mu-1 is utilized during leak testing of flexible endoscopes.The mb-155 is an accessory connected to the mu-1 for the purposes of leakage testing.The mu-1, s/n (b)(4), was returned for evaluation, but the mb-155 was not returned.The mu-1 had no visual defects with the output connector, air joint and internal component parts.No blockage or debris was observed inside the pump tubing lines.The device passed functional inspection with an olympus airflow checker.The pressure and flow rate readings were within output specification, and the device functioned normally.The facility was informed of the device evaluation results.Minor repairs were performed due to wear and tear of the air joint and connector socket.A plastic cover for the power switch was also replaced as it was missing when returned.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the user facility.Olympus was informed that the 14 patients developed esbl ecoli infections after undergoing ercp procedures using the tjf-q180v duodenovideoscope.To date above 70 patients have been notified due to their exposure to the device.Although, the scope cultured negative for microbial growth it has remained isolated since (b)(6) 2016.On november 1, 2016 olympus received a mandatory medwatch ((b)(4)) form which reported that a patient developed an extended-spectrum beta-lactamase (esbl) ecoli infection and expired after undergoing an endoscopic retrograde pancreatography (ercp) procedure using a duodenovideoscope.The medwatch reports that patient's procedure was completed with no noted complication at that time.On (b)(6) 2016, the patient presented to an outside hospital emergency department symptomatic with complaints of diffuse radiating pain throughout her abdomen on a scale of (8/10) with associated nausea, vomiting, shortness of breath, chills and constipation with last bowel movement several days prior despite the use of laxatives.The patient denied having a fever.It was reported that patient' symptom began at home and prior to arriving at the emergency department the patient took three doses of morphine but the pain persisted the patient's reported vital signs upon arrival included: bp 68/42, hr 120, t 98.1 °f (36.7 °c), rr 20, 02 saturation 95 % on ra.Patient was given a fluid bolus with normal saline and was started on 1000 mg iv ertapenem.The medwatch reports that it was decided that patient would pursue comfort care.Care was transitioned to palliative care and the patient was discharged with home hospice.In addition, the medwatch states the (b)(6) was not notified of the patient's death until 7/26/16 from the patient's referring md.Reportedly, the user facility's infection control requested the outside hospital culture isolates for pfge testing.Based on the new information olympus filed four initial mdrs to account for 1 patient death and 3 additional patient infections.Please also cross reference the following reported events with mfr.Report numbers: 2951238-2016-00414, 2951238-2016-00414, 2951238-2016-00318, 2951238-2016-00319, 2951238-2016-0070, 2951238-2016-0071, 2951238-2016-0072, 2951238-2016-0073, 2951238-2016-0074, 2951238-2016-0075, 2951238-2016-00878, 2951238-2016-00879, 2951238-2016-00880 and 2951238-2016-00881.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo, 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5456009
• MDR Text Key: 38857190
• Report Number: 2951238-2016-00074
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Device Catalogue Number: TJF-Q180V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2012
• 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
• Treatment: ACECIDE-C (DISINFECTANT SOLUTION)
• Patient Outcome(s): Required Intervention