MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE

Model Number BF-Q180

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center and is pending evaluation.The cause of the reported event cannot be determine at this time.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 on (b)(6) 2020 culture samples were taken from the scope after reprocessing.The user facility reported that results received on (b)(6) 2020, show the scope cultured positive for positive for stenotrophomonas maltophilia.The scope was cultured twice and both results were positive.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information.Additional information received from the customer states the facility has top level reprocessing and have the best practice in regards to their reprocessing methods.The facility performs residual protein testing and have had no positive cultures in the past three years.It is believed that the current positive cultures are due to the channels being so thin.There has been no patient infection.The customer were not able to put the borescope into the channel like other scopes to check for defects, damage, etc.The facility has ordered a thinner borescope to check the channels of these scopes to ensure there is no internal damage.The scopes are cultures every week as a part of contingency.The scopes are reprocessed with opa.The scope is reprocessed in a medivators aer and the ifu is followed.The scope is stored in a hanging dry closet.All reprocessing staff are trained on how to properly reprocess the scopes.Pre-cleaning is being performed.Internal inspection of the channels are being performed after the reprocessing.An olympus leak tester is being used.The channels are being brushed during manual cleaning.The customer declined the offer to send the scope to the independent laboratory for microbial testing.There was no patient infection or injury due to this.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and lm investigation.The bf-q180 video scope, serial number 2545714 was forwarded to market quality for evaluation.Market quality performed a visual inspection on the received device.The biopsy channel was inspected with an olympus boroscope and scrape marks were located near the middle section.The biopsy channel has no stains, or foreign material within.The bending section cover glue on both sides is non-olympus.Additionally, the adhesive surrounding the objective and light guide lenses is also non-olympus.The video scope passed the cosmo leak test (+.4).The last service event in may of 2020 consisted of the device being return unrepaired.In addition, 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: the legal manufacturer cannot conclusively specify the cause of the suggested event.Since result of culture test by the user was positive and third-party repair was performed, we presume the following causes: 1.Reprocessing process conducted by the user was different from the process recommended in ifu, which led to insufficient reprocessing.2.Caontamination occurred during culture testing at the user.3.Performance of cleaning/disinfection/sterilization was lost due to third-party repair.2-6.Labeling review: ifu states as follows: ·insufficient 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.Third-party repair: olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-olympus personnel.The suggested event was positive culture test, not defect of the device.No report on patient injury or infection.The legal manufacturer confirmed the subject scope was shipped in accordance with specifications via dhr.

Manufacturer Narrative

This supplemental report is being submitted to report additional information.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 made multiple attempts to schedule this visit; however, due to no response from the customer no observation /in-service has been performed.

• Brand Name: EVIS EXERAII BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11012132
• MDR Text Key: 221556562
• Report Number: 8010047-2020-10390
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2021

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: BF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 06/10/2021; 06/14/2021
• Supplement Dates FDA Received: 01/13/2021; 06/12/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1