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

Model Number PCF-H190DL

Device Problem Increase in Pressure (1491)

Patient Problem Tissue Damage (2104)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

The referenced scope was returned to the manufacturer for evaluation.Test equipment (flushing pump, instrument channel adapter and auxiliary water tube) was used with the scope for evaluation.The foot switch and a jet stream of constant flow was observed exiting the distal end of the scope; the jet stream has an abnormal angle when exiting (not straight).Additionally, the flow rate was tested by an incremental setting of 1 on the flushing pump.Excessive pressure was confirmed.At each increment, a higher stream of force/pressure was exiting the distal end of the scope.At maximum flow rate (9), the water jet flow was exiting the distal end at a higher pressure which can be observed, heard and felt which is indicative of the user¿s experience.Further testing was performed; during activation of the foot switch the water stops exiting from the distal end, droplets of water was observed at the distal end auxiliary channel.The auxiliary channel opening was inspected under a microscope and foreign debris was to found to be clogging the channel, causing blockage.The foreign debris was removed from the auxiliary channel and found clear hard residue/debris.The activation of the flushing pump flow rate was normal after the removal of the debris from the auxiliary channel from the scope; testing was perform under low, medium, and max settings on the flushing pump; water flow was at a normal rate.The scope passed the leak test.The scope was repaired and returned to the user facility.A review of the scope¿s instrument history indicates the scope purchased on january 3, 2018 and was last repaired on april 19, 2019.Based on evaluations and findings, the most probable cause of the reported patient injury was attributed to a clogged auxiliary channel resulting in a build-up of pressure.As a preventive measure, the instruction for use (ifu) manual instructs users to prepare and inspect the scope before use (chapter 3).The ifu (page 70) also provides warning and caution which state: nothing other than sterile water should be used for auxiliary water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and/or infection.When the auxiliary water tube is not connected to the auxiliary water inlet, attach the auxiliary water inlet cap to the auxiliary water inlet and cover the auxiliary inlet.Otherwise, patient debris or fluids that flow backward may drip out of the auxiliary water inlet.The reprocessing manual states confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been stored properly.The reprocessing manual also instructs to dry the external surfaces of the endoscope, the channel plug, the injection tube, and the auxiliary water tube by wiping with clean lint-free cloths.Inspect all items for residual debris.Should any debris remain, repeat the entire cleaning procedure until all debris is removed.

Event Description

The manufacturer was informed that during the beginning of a colonoscopy procedure, when using the waterjet the pressure coming out of the scope reportedly caused superficial mucosal tears to the patient¿s right colon.The use of the waterjet was stopped and manual flushing was done as needed.The flushing pump was removed and the procedure was completed with hand irrigation.There was no further treatment needed to the patient.The user facility reported the flushing pump settings were on low and rechecked at time of injury.The flushing pump was sent to the facility's biomedical engineer for testing and no fault was found.In addition, the scope had been used approximately for ten procedures prior to the issue.There are six physicians that use the scope; all have different techniques.Some prefer manual flushing, some use the flushing pump minimally.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8642634
• MDR Text Key: 146223336
• Report Number: 2951238-2019-00881
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• 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
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other