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

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

The scope has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Currently the investigation is ongoing.As part of our investigation, an olympus endoscopy support specialist (ess) will be dispatched to the user facility to observe the reprocessing technique of the technicians involved with this scope.Olympus will continue to investigate and work with the user facility to obtain more specific and detailed information regarding the reported event.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a post market surveillance study, the scope tested positive for staphylococcus lugdunensis.

Manufacturer Narrative

As part of our investigation, an olympus endoscopy support specialist was dispatched to perform an onsite inspection of the user facility¿s aer.The daily inspection prior to first use was performed as directed by aer ifu on the day the sample was collected.The ess reported that a review of the aer¿s error log was performed and revealed no errors occurred during the cycle for the scope.Aer¿s manufacture recommends maintenance period 1 year.The aer¿s last periodic maintenance was performed on june 14, 2018.Aer¿s manufacturer recommends filter replacement every 6 months.Customer was unable to provide date of the last change on aer water filter.Last disinfection cycle was complete on june 19, 2018 based on aer ifu performed after changing of the filter.As part of the pms study investigation, an olympus engineer was dispatched to the user facility to observe the scope sampler¿s technique.The engineer reported that there were no deviations noted during the sampling observation.The olympus endotherapy support specialist (ess) performed a review of the reprocessing technique.The ess noted that the brushing of the distal tip and channels were completed out of sequence according to the reprocessing manual.The re-culturing test was performed as part of our investigation, and found sample was tested positive for bacillus cereus (1cfu).As part of the pms study, the scope was sent an independent laboratory for ethylene oxide (eto) sterilization and returned to service center for a physical device evaluation.A visual inspection was performed on the returned device and discovered a kink, as well as discoloration and scrapes inside the biopsy and suction channels when using the olympus boroscope.The kink inside the biopsy channel is located at the entry near the distal end opening at approximately 30mm.The brownish stain around the wall of the biopsy channel was located at the opening near the distal end side.Furthermore, brownish spots were discovered inside the biopsy channel at the 10cm marking (insertion tube) from the control body side.Service center also used the boroscope to verify the condition of the suction channel, which has a scrape near the scope connector side; however, there are no signs of foreign material present within.The scope passed the leak test.The scope was purchased on november 19 2018, and resold on (b)(4) 2019.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.As part of the pms study investigation, an olympus engineer was dispatched to the user facility to observe the scope sampler¿s technique.The engineer reported that there were deviations noted during the sampling observation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the site visit performed by the endoscopy support specialist (ess).The ess provided instruction on the importance of following the specific brushing sequence as listed on the olympus reprocessing manual.Also, provided additional instruction on checking connectors for wear and tear at start of each cycle and verifying that fluid exits holes on the top of all connecting tubes in the oer-pro.Reprocessing tech demonstrated back the correct steps for both brushing and inspection of connecting tubes.The ess completed the in-service on january 25, 2019.During the visit, the reprocessing technician at the user facility reported that the aer connector was broken on the day that the scope was cultured.The reprocessing technician informed olympus personnel on that day and the connector was immediately replaced.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation conclusion.The device was returned for the evaluation.Olympus submitted the sampling and culturing study interim report of the tjf-q180v on october 30, 2019.Based upon evaluation, a root cause of this case is following; insufficient reprocessing due to improper reprocessing procedure and/or contamination due to improper sampling are probable causes.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8268959
• MDR Text Key: 133847444
• Report Number: 2951238-2019-00387
• Device Sequence Number: 1
• Product Code: FDT
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS OER PRO