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

Model Number TJF-160VF

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.The customer performs a leak test after each use of the scope.The device is reprocessed with an automatic reprocessor.The scope is being stored hanging in a scope closet.Supplemental report(s) will be filed as any further information becomes available.The device is return and an evaluation completed for it.Device manufacture date is not known.The user¿s complaint was confirmed.Upon evaluation, the elevator wire was observed to be broken with no movement in the downward direction.Other incidental finding were a crack on the on the light guide lens, chip on the objective lens, not affecting functionality, and some surface scratches.The cause for the broken elevator could not be determined.

Event Description

As reported for this event, during the middle of the therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure the elevator broke while cannulating was being performed.There was metal protruding.No parts of the device fell into the patient.The bending section was not broken.There was a delay of five minutes while the patient was under anesthesia.There was no adverse impact, including no mucosa tears, to the patient.The procedure was completed with another similar device.No other devices were replaced for this procedure.There was no issue withdrawing the device from the patient.The device was inspected prior to use and no damage or abnormalities were observed.There was no visual deformation noted on the bending section of the scope.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Reported issue of the device is the elevator broke.The forceps elevator does not move even when the forceps lever is operated (it remains raised and cannot be moved).The device history record review confirmed that device satisfied delivery standard before shipment from the factory.Upon evaluation, the elevator k-wire was observed to be broken, frayed with no movement in the downward direction.Root cause cannot be conclusively determined.However, a likely cause is k-wire fatigue fracture due to repeated operations of forceps elevator.To prevent occurrence of health hazard and so that users can easily detect broken k-wires.Caution statements are added to the instruction manual and the attachment calls attention to it.A capa is open for a similar device for this issue.

• Brand Name: EVIS EXERA 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: 10408560
• MDR Text Key: 202971378
• Report Number: 8010047-2020-05485
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-160VF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1