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

Model Number TJF-Q180V

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.There was leaking noted between the control body and the bending section cover.There were also, dents and scratches noted on the control body.A portion of the bending section rubber was found missing and the bending section glue was noted to be cracked on the bending section cover and insertion tube.Further inspection found the light guide lens was dirt and chipped.The objective lens had old glue.The elevator lever showed signs of corrosion/discoloration.The instruction manual provides warnings to prevent damage to the endoscope and how to ensure to inspect the elevator lever.Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Inspect the forceps elevator and the area which can be visually accessible in elevator recess, while raising and lowering the forceps elevator to confirm that there is not any foreign materials, such as debris and fluids, but not limited to.If any foreign materials is observed, stop using the endoscope and take necessary measures according to section 6.2, ¿inspection before each patient procedure¿ on page 74.

Event Description

The service center was informed that the scope improperly reprocessed as the scope cleaning was delayed.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.As the results of the dhr review, it was confirmed that the subject scope was shipped in accordance with specifications.The legal manufacturer reported that the most probably cause for the reported events are as follow: phenomenon: gap of adhesive on the distal end / stain entered inside the lens through the gap.The legal manufacturer reported that the event may have occurred by physical stress and/or chemical stress.It may also have been due to poor environment of storing (direct rays of the sun, too hot, highly humid, exposed to x-ray/ultra violet ray, etc.) and/or deterioration by aging, as well.Phenomenon: inspection requested after delayed reprocessing.The cause of the event cannot be conclusively determined.The legal manufacturer would like the user to perform immediate reprocessing after use, in accordance with ifu.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 10708510
• MDR Text Key: 224663653
• Report Number: 8010047-2020-07916
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/18/2020
• 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