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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service and is pending evaluation.An investigation is ongoing to obtain additional information regarding the reported event.As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.To date, the ess visit has not been finalized.

Event Description

The service center was informed that the scope cultured positive for an unknown organism.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation, ess outcome and lm investigation.Please see the updates in sections: g4, g7, h2, h4, h6 and h10.The customer declined the ess visit for a reprocessing observation and in-service.In addition, the scope was sent to an independent laboratory for testing and no microbial growth was found on scope for testing.The scope was eto sterilized and returned to the service center for evaluation.The tjf-q180v video scope, serial number (b)(6) was forwarded to olympus market quality for evaluation due to ¿positive culture.¿ a visual inspection performed on the received condition and found stains inside of the biopsy and suction channels.The channels were inspected with an olympus boroscope.The biopsy channel was first inspected with the boroscope and noted brownish stains on the forceps elevator, and biopsy channel.The stain inside the biopsy channel appears near the channel opening at the distal end side.The suction channel was also inspected, and multiple stains were found at the opening near the scope connector side.Both ends of the bending section cover glue are discolored with cracks and pinholes.In addition, the objective lens glue also has pinholes.The video scope is failing the leak test at the seam of the control body.The last service event was back in 2018.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: though it is difficult to specify the cause of the suggested events, we presume the following via positive culture test by the user, negative culture test by the third-party lab and device inspection result.-1.Reprocessing process conducted by the user was different from the process recommended in ifu, which led to insufficient reprocessing.-2.Contamination occurred during culture testing at the user.Ifu states as follows: reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿channel outlet¿ states on detailed process of reprocessing under forceps elevator as follows: 7.While holding the distal end, insert the soft brush or the channel-opening cleaning brush (mh-507) or single use channel-opening cleaning brush (maj-1339) into the interior of the forceps elevator.Turn the inserted brush once, then pull it out.8.Brush both sides of the forceps elevator using the soft brush or the channel-opening cleaning brush (mh-507) or single use channel-opening cleaning brush (maj-1339) the legal manufacturer confirmed the subject scope was shipped in accordance with specifications via dhr.

• 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: 10856032
• MDR Text Key: 225931120
• Report Number: 8010047-2020-09028
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1