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

Model Number TJF-Q180V

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint of ¿ the forcep elevator does not move down¿ was not confirmed.The scope¿s forcep elevator and lever functioned normal.The bending section rubber glue was found cracked on the bending section cover and insertion tube.There were also minor scratches observed on the scope¿s insertion tube.A tiny chip was noted on the edge of the light guide lens.Minor scratches and a dent were observed on the light guide tube.

Event Description

The service center was informed that during reprocessing, the forceps elevator of the scope will not move down at all.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The customer¿s complaint of the elevator would not go up/down was not confirmed.Images taken show the elevator up.The legal manufacturer was unable to determine the root cause.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10857315
• MDR Text Key: 225931061
• Report Number: 8010047-2020-09048
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

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: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 02/08/2021; 03/30/2021
• Supplement Dates FDA Received: 03/08/2021; 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1