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

Model Number TJF-Q180V

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.We were unable to duplicate the user report, elevator is working properly.The control knob movement was found to have loose play in all directions.The scope failed the leak test due to damage on the bending section cover.The plastic cover on the control body of the scope was noted to have dents.The bending section glue was found to be cracked on the bending section cover and insertion tube.The insertion was also noted to be buckled.Scratches were noted on the objective lens without affecting the image.Further investigation found the light guide tube buckled.The likely cause for the reported event is user mishandling.The scope was repaired and returned to the customer.The instructions for use state: 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.

Event Description

The service center was informed that during preparation for use, the forceps elevator was noted to be loose and would not move up or down.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer final investigation.As stated previously the reported event was not confirmed during the evaluation step of the complaint process.However, the suggested event possibly occurred temporarily in the user facility.In addition, an investigation was performed by the legal manufacturer based off of the information provided.A review of the dhr was performed and there were no issues found within the record associated to the reported event.A root cause could not be definitively identified.Based on the results of the investigation and additional information that was provided, the following is the most likely cause to the reported complaint.On the basis of the following information, the foreign material might have attached around the forceps elevator, and movement of the forceps elevator possibly be disturbed temporarily.Suggested event was not able to be reproduced by olympus.Suggested event possibly occurred temporarily at the user facility.In the former complaint of the subject device, a foreign material adhered to around the forceps elevator.

• 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
• MDR Report Key: 10920611
• MDR Text Key: 221297786
• Report Number: 8010047-2020-09612
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1