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).Olympus (b)(4) checked the subject device for evaluation.It was confirmed that there was the foreign object at the backside of the forceps elevator of the subject device.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 that during the repair at olympus (b)(4), it was found the foreign object at the backside of the forceps elevator of the subject device.The subject device had been returned to olympus india for repair of the leakage from the bending rubber part.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.[conclusion] the root cause of the reported phenomenon could not be identified.[considerations] from the investigation results of evaluation of olympus india and the former similar case, omsc presumed that the reported phenomenon occurred due to the following handlings; a) insufficient user¿s reprocessing around the forceps elevator after the procedure.B) foreign matter adhering to the forceps elevator dried and stuck because the user did not perform the reprocess immediately after the procedure. ifu (reprocessing manual) states regarding brushing method around forceps elevator as follows: 3.5 manual cleaning: brushing around the forceps elevator and instrument channel outlet moreover, ifu (reprocessing manual) states as follows: 3.3 precleaning: if the endoscope is not immediately precleaned, residual organic debris will begin to solidify, and it may be difficult to effectively reprocess the endoscope.From above, we presume that the reported phenomenon could be prevented.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: 12860176
• MDR Text Key: 284520106
• Report Number: 8010047-2021-14926
• 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: 12/30/2021

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: 10/07/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2010
• 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