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

Model Number TJF-Q180V

Device Problem Residue After Decontamination (2325)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been investigated by the manufacturer yet.Therefore the exact cause of the reported has not been conclusively determined.This report will be supplemented once the investigation has been concluded.

Event Description

A technical service engineer of olympus medical systems (b)(4) private limited reported that foreign materials adhered to the distal end of the device.No patient was involved in this event.The device was inspected by olympus because the customer reported that the device failed a leakage testing due to a damage on the bending section after an endoscopy.There is no other information provided at this moment.This report will be supplemented if additional information is available.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The field service engineer (fse) of olympus informed that the user facility had conducted reprocessing according to our recommendation.The fse will arrange one more reprocessing training for the user facility.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.

• 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: 11092898
• MDR Text Key: 225248860
• Report Number: 8010047-2020-11115
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1