MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DUODENOVIDEOSCOPE

Model Number TJF-150

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 inspected at omsi.Omsi checked the subject device and found that the reported phenomenon was caused by insufficient cleaning.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 incoming inspection for repair at the service department of olympus (b)(4), it was found that there was foreign material on the forceps elevator.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.There was the possibility that insufficiently or incorrectly reprocessed subject device might be used for next procedure.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.However, based upon the reported information and similar past cases, omsc surmised that this reported phenomenon was attributed to the following.- there was a difference between the brushing method for the forceps elevator performed by the user facility and the brushing method recommended by the instruction manual.- the staff of the user facility had not been trained sufficiently on the handling of the subject device, the reprocessing of the subject device after repair, or the usual reprocessing, according to the instruction manual.If additional information becomes available, this report will be supplemented.

• Brand Name: 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: 12953199
• MDR Text Key: 283078913
• Report Number: 8010047-2021-15657
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K954451
• 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: 02/21/2022

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-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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