MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, olympus followed up with the user facility and the nurse manager reported "the state has deemed that per our records the infection did not come from us, but they ¿strongly recommend¿ that we continue to quarantine and culture the scope.We have been cleared, so i really can¿t answer the patient questions".The scope was returned to olympus but the evaluation is in progress.The subject scope was forwarded to an independent laboratory for microbial testing.In addition, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that after the scope was used on a patient in a procedure, the patient came back with an unspecified infection.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information, the device evaluation results, the independent laboratory results and the olympus endoscopy support specialist's (ess) investigation.The nurse manager reported their scope culture tested negative cultures and the user facility was cleared by the new mexico department of health.No further information was made available.As part of our investigation, the olympus ess was dispatched to observe the user facility¿s reprocessing and to provide an in-service.The ess reported that the staff demonstrated pre-cleaning, leak testing and their manual cleaning process.The ess noted that not all of the facility¿s staff was performing the leak testing in accordance to the olympus reprocessing manual.The ess observed the leak tester connector would remain attached throughout the user facility¿s manual cleaning process.The ess provided correction when to properly detach the leak tester connector from the scope for depressurization.In addition, the ess also provided an in-service to the staff, which included a demonstration of all cleaning, disinfecting and sterilization information contained in the olympus endoscope-reprocessing manual.The scope was sent to an independent laboratory for microbial testing.The scope was cultured and the test results indicated the scope's the scope's distal end and elevator mechanism tested positive for micrococcus luteus and the instrument/suction channel tested positive for staphylococcus epidermidis.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.A visual inspection was performed on the biopsy channel with an olympus borescope and found a scrape mark at approximately 50mm from the channel opening at the distal end of the scope.The suction channel was also inspected and no damages or abnormalities were noted.There were no signs of any foreign material within either channel; however, discoloration was noted on both sides of the bending section cover glue.The scope failed the leak test due to a leak noted between the scope¿s distal end cover and distal end cover body.A review of the scopes instrument history record indicates the scope was purchased on may 27, 2014 and was serviced on june 30, 2016.The exact cause of the reported patient infection could not be confirmed.However, as a preventive measure, the reprocessing manual states, ¿an insufficiently cleaned, disinfected, or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them." the instruction manual (page 72) states, "send the endoscope to olympus for inspection of the forceps elevator by olympus once a year.".

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8580500
• MDR Text Key: 144099616
• Report Number: 2951238-2019-00801
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/04/2019
• Supplement Dates Manufacturer Received: 05/11/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention