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

Model Number TJF-Q180V

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service center for evaluation.A review of the scope's history shows the scope was last repaired (major overhaul) on (b)(6) 2020.The evaluation confirmed the reported elevator does not go all the way down as the elevator was found loose.Additionally, there were dents and scratches on the distal end cover, a minor chip on the edge of the distal light guide lens and a minor buckle on the insertion tube.The scope passed the leak test.The scope was repaired back to standard specification and returned to the customer.The investigation is ongoing, therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed by the customer that the evis exera ii duodeno-videoscope 's forceps elevator does not go all the way down.No patient injury or harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the event occurred because of deterioration by usage causing a very small gap between the distal tip and the arm cover.As a result, water or chemical solution entered into the gap, crystalized, hindered movement of the l-arm, and the forceps elevator was unable to move to low position.The following description is included in instructions for use to prevent the reported event: "important information - please read before use: warnings and caution: 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." per the legal manufacturer, the other device defects noted in the initial report have no potential to cause or contribute to death or serious injury if the malfunction were to recur (dents, scratches, chips and buckle on the insertion tube).

• 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: 10866598
• MDR Text Key: 225940716
• Report Number: 8010047-2020-09146
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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: Other
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1