MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE

Model Number	CF-HQ190L
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope was returned to olympus for evaluation, the service group could not confirm the cause of the reported event as a visual inspection was performed using a borescope and there was no note of foreign objects inside the biopsy channel, however, there was a note of red stain inside the channel and the bending section cover glue at the distal end of the insertion tube was found peeling.A review of the scope¿s instrument history record indicates the scope was purchased on november 11, 2014 and was last repaired on february 15, 2019.The scope was repaired and returned to the user facility.As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event.There were no other endotherapy devices used during the procedure.The "foreign polyp" was tested and sent to the lab.The patient was injected with hepatitis b immune globulin and blood tests were performed.The results of test are not known at this time.In addition, the user facility reported there was no endotherapy accessory inserted into the biopsy channel to inspect the channel prior to procedure, as the facility stated "it is not a standard procedure to check the biopsy channel in the procedure rooms.¿ for reprocessing, pre-cleaning is being performed immediately after a procedure as per the manufacturer instruction/reprocessing manual (ifu).Prior to manual cleaning, the scope is being leak tested with the olympus mu-1.During manual cleaning, the scope channel is being brushed with the olympus bw-412t.The user facility utilizes an automated endoscope reprocessor (aer), olympus oer-pro, to perform high level disinfection.The last preventive maintenance for the aer was on january 23, 2019.The date of the last reprocessing in-service conducted by an olympus reprocessing specialist on november 18, 2018.All reprocessing personnel are trained on how to properly reprocess an endoscope.The endoscope is being stored and vertically hung in a roll top scope cabinet.Based on the information reported, the most probable cause of the reported event can be attributed to not inserting a endotherapy device prior to procedure.As a preventive measure, the instruction manual states ¿before each case, to prepare and inspect the endoscope as instructed.When inspecting 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.¿.
Event or Problem Description
Olympus was informed that during a colonoscopy procedure, the physician went to insert a non-olympus snare into biopsy channel of the scope and a ¿foreign polyp¿ came out.It was believed the foreign poly did not come out of the scope after cleaning and disinfection as no polyp had been removed from the patient yet.The registered nurse (rn), mentioned they did not feel resistance at all when introducing the snare.The rn mentioned the "foreign polyp¿ did not fall in the patient but they noticed it on the monitor and was stuck in the sheath of the device.The ¿foreign polyp¿ was retrieved as they removed the device on which the "foreign" polyp object was stuck.The same scope was used to complete the procedure.There was no patient injury or infection reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the origingal equipment manufacturer¿s (oem) investigation results.During the onsite visit by the clinical specialist to observe the pre-cleaning, pre-cleaning was performed immediately after the completion of the procedure, however, it was noted that depending on who was performing pre-cleaning immediately after the completion of a procedure, it was being done in a very inconsistent manner.The scope was returned to the oem, however, based on the pictures provided from the physical evaluation, the oem noted the blood stains that were observed during the physical evaluation were likely not blood-origin stains but that of a red oil-based ink marked on the outer wall of the biopsy channel.The outer wall of the biopsy channel is marked during the assembling process.The biopsy channel has the outer porous layer and the transparent inner substantial layer.Therefore, red marks on the outer porous layer may have seeped onto the transparent inner substantial layer.The cause of this event cannot be conclusively determined.However, the most probable of the reported event was attributed to inadequately brushing of the scope and not following ifu (by perform pre-cleaning immediately after each procedure).As a preventive measure, the ifu provides warning statements on the risk when precleaning is not performed immediately after each patient procedure; - 5.3 precleaning the endoscope and accessories:warning:if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Precleaning the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure.Additionally, a review of the dhr found no anomalies during the manufacturing process.

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8493183
• Report Number: 2951238-2019-00711
• Device Sequence Number: 14628846
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (Y/N): N
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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
• Operator of Device: No Information
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SNARE: BOSTON SCIENTIFIC (MODEL/SERIAL: UNK)