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

Model Number TJF-Q180V

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center and is pending evaluation.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

It was reported by the user the forceps elevator of a evis exera ii duodenovideoscope could not be raised or lowered.In addition, the customer reported a "nick" on the plastic end of the scope that could have caused the phenomenon.There was no report of patient involvement or injury.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation, additional feedback from the user facility and to correct information provided on the initial report.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 legal manufacturer's investigation, it is likely the cover was deformed by the impact due to user's mishandling, which disturbed the operation of the forceps elevator.The user can detect the suggested event appropriately by handling the device in accordance with the instructions for use, identified in the following verbiage: "inspection of the endoscope - inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." the user can prevent / reduce the suggested event by handling the device in accordance with the instructions for use, identified in the following verbiage: "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".

Event Description

Received an email from user facility on 05mar2021.The issue was noted to have occurred during reprocessing on (b)(6) 2021.The device had failed a 5 day lapse inspection upon cleaning it.A patient was not involved.No other devices were involved in this event.

• 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: 11364575
• MDR Text Key: 233176255
• Report Number: 8010047-2021-02894
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• 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: 03/15/2021

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: 02/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1