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

Model Number GIF-H180J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.The reprocessing steps taken by the customer are as follows: the channel is manually brushed after each procedure with a disposable brush.The third-party brush is made by diversatek healthcare reference number (b)(4), lot number 002297.The device was reprocessed per guidelines after the brush was found and removed.The device is reprocessed in an oer-pro (automatic reprocessing machine) intended for olympus devices only.The cleaning and disinfectant solution being used is intercept.The minimum effective concentration is being checked after each device.Pre-cleaning is being performed immediately after a procedure.The device is set on the counter to do a leak test.The device is put into water to check if there is a leak.Once this is done, the device is put into the water with the disinfectant and it is cleaned with the disposable brush.The brush is put through the channel of the device all the way down to the camera and it is brought back through the device channel and it is checked to make sure there is no residue.The brush is then discarded after it is cleaned.There is no flushing of air into the channel.However, that all of the water comes out of the device is ensured.The device is being stored by hanging.The device will not be sent in to olympus as the device does not need to be repaired as there was no damage to the device and the brush tip found was removed during manual brushing.The reprocessing in service was provided a few months previously.There are three staff members performing reprocessing.All of the reprocessing personnel is trained on how to properly reprocess the device and in the use of the oer-pro.Supplemental report(s) will be filed as any further information becomes available.

Event Description

As reported for this event, during reprocessing after a diagnostic upper endoscopy (edg) procedure, the customer swapped to a third-party brush with suction-cups on the end.There was no resistance or obstruction to the brush in going down the channel; however, when pulling the brush back through the channel an object was felt, and the tip of another brush came out of the device.Both the original brush used and the third-party brush were intact.Nor were there any missing brush pieces from the earlier reprocessing of the device.The origin of the brush tip or how the brush tip was in the device is not known.The procedure for which the device was used was completed with this device; there is no adverse impact to the patient arising from this issue and the device was not cultured.The device had been inspected prior to procedure and no damage or abnormalities were observed, nor was the brush tip seen in the device prior to or during the procedure.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communications.This supplemental report is being submitted to provide this information.The device history record review confirmed that device conformed to specifications in manufacturing.The device will not be sent in to olympus as the device does not need to be repaired as there was no damage to the device and the brush tip found was removed during manual brushing.The customer uses third-party brush.The origin of the brush tip or how the brush tip was in the device is not known.Customer said they follow procedure for reprocessing.The issue of the brush tip coming out of the device is likely due to the user handling/reprocessing, not due to specifications of the device.The instructions for use includes the following statements: for inspection of the instrument channel: ·insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.Reprocessing manual: the channel cleaning brush (bw-20t) is consumable.The single use channel cleaning brush (bw-201t) and the single.Use combination cleaning brush (bw-412t) are for single use.Repeated usage of these brushes may cause the brush head to become bent or kinked, which could cause it to come off during use.Confirm that the brush is free from any damage or other irregularities before and after use.If a piece of the brush comes off inside the endoscope channel, immediately retrieve it.Confirm that no parts remain inside either the instrument channel or the suction channel of the endoscope by carefully passing a new brush through both channels.Any part left in the channels can drop into the patient during a subsequent patient procedure.Depending on the location of the missing part, the part may not be retrievable by passing a new brush.In this case, contact olympus.·do not attempt to pass the channel cleaning brush or the single use channel cleaning brush backwards ¿ i.E., by inserting the brush directly into the open end of the instrument channel at the distal end of the endoscope¿s insertion section or directly into the suction connector on the endoscope connector.It may get caught, making retrieval impossible.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10414005
• MDR Text Key: 203150593
• Report Number: 8010047-2020-05514
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (y/n): N
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1