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

Model Number TJF-Q180V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4) but has not been returned to omsc.Olympus (b)(4) checked the subject device for evaluation.It was confirmed that it was found the forceps elevator of the subject device had the foreign object, and the dirt inside the light guide lens of the subject device.As for the foreign object on the forceps elevator, it might have occurred due to insufficient cleaning or handling problem.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed during the incoming inspection for repair at olympus (b)(4), that it was found the forceps elevator of the subject device had the foreign object, and the dirt inside the light guide lens of the subject device.The subject device had been returned from the user because the elevator wire was broken and the forceps raiser was not moving up completely.The occurrence date of the event is unknown.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.It could not be identified the root causes of the reported phenomena.However based on the report of olympus india, omsc presumed as follows; [the forceps elevator of the subject device had the foreign object] -since the forceps elevator wire be completely cut off, it became impossible to operate the forceps elevator, and the forceps table was insufficiently cleaned, and foreign object might have been remained.-there might have been a difference between the reprocess method implemented by the user facility and the reprocess method recommended by the instructions for safe use (ifu).[there was the dirt inside the light guide lens] from the evaluation report of olympus india and their inspection results, it was presumed that the internal components of the light guide lens might have been corroded due to the infiltration of moisture into the subject device, and the products by the corrosion might have remained inside the light guide lens as dirt.If additional information becomes available, this report will be supplemented.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12669633
• MDR Text Key: 281402589
• Report Number: 8010047-2021-13452
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

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 Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/20/2021
• Supplement Dates FDA Received: 12/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1