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

Model Number GIF-2TH180

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The endoscopy support specialist (ess) communicated to the customer that the issue usually stems from not performing the bedside cleaning correctly, therefore debris is left behind.If the scope sits for any length of time, that debris hardens to the point that the normal cleaning process cannot remove it all.The channels still have residual moisture in the channels after it comes out of the automated endoscope reprocessor (aer).As that residual moisture sits on the debris, it loosens it to the point that as the scope hangs to gravity dry, the loosened debris drips out of the distal tip.This can easily occur on a dual channel scope if the correct bedside cleaning is not performed correctly, which requires more than a general gastrointestinal scope.The ess also performed an in-service visit to observe the user facility¿s reprocessing practices from start to finish and provided a reprocessing in-service training to correct and address any reprocessing deviations.In addition, the ess sent delayed reprocessing instructions and the correct connection information when using an oer-pro.The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported while preparing for a procedure, an evis exera ii gastrointestinal videoscope was pulled out of a cabinet and there was blood dripping from it.The scope had been reprocessed the day before and was not used on any other patients.No patient involvement was reported.It was stated that at times, a scope would be reprocessed and when moved from the washer to the transfer case, debris would leak out of it, at which time the scope was reprocessed.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The dhr review could not be performed as no lot number was reported and there was no device return to inspect for a lot number.If the lot number becomes available at a later date, the dhr shall be reviewed.The probable cause of the reported issue was due to the delay of the reprocessing after the procedure.It is considered that the residue that was difficult to remove due to the sticking of the residue fell from the tip of the scope together with the residual water in the scope.The ifu (instruction for use) provides guidelines: precleaning: if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin solidify and it may be too difficult to effectively reprocess the endoscope.Preclean the endoscope at the bedside in the procedure room immediately after each procedure.Corrected data: correction: initial aware date on the initial medwatch report should have been reported as february 12, 2021.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11422829
• MDR Text Key: 244802094
• Report Number: 8010047-2021-03374
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339752
• UDI-Public: 04953170339752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1