MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DUODENOVIDEOSCOPE

Model Number TJF-150

Device Problems Device Reprocessing Problem (1091); 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 and found that the reported phenomenon which 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 during the incoming inspection for repair at olympus (b)(4), that it was found there was the foreign object on the distal end of the subject device.The subject device had been returned to olympus (b)(4) for repair of the leakage of the instrumental channel.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 corrected and additional information.Regarding the previous initial report of #8010047-2021-15083, olympus medical systems corp.(omsc) noticed that "g3: date manufacturer received" was incorrect.The correct date is "(b)(6), 2021", not " (b)(6), 2021"." (b)(6) 2021" is occurrence/finding date of " there was the foreign object on the distal end, the exact part of which was on the forceps elevator at the distal end of the subject device¿.In addition, omsc reviewed the evaluation report of olympus india and found a sign of insufficient or incorrect reprocessing the subject device due to the presence of the foreign object on the forceps elevator of the distal end of the subject device (the user may have used the poor reprocessing subject device for next procedure).If additional information becomes available, this report will be supplemented.

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.The root cause of the reported phenomena could not be identified.[consideration] it was unable to specify the cause of the reported phenomena.However, since dirt and appearance defects of the subject device that may have been caused by device handling at the user facility was confirmed, it was presumed the following.-there was possibility that brushing method by user facility was different from the one recommended by ifu.- there was possibility that it was insufficient training on device handling, reprocessing steps when returning device for repair and normal reprocessing steps in accordance with ifu.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: 12874530
• MDR Text Key: 284105209
• Report Number: 8010047-2021-15083
• 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,Followup
• Report Date: 03/08/2022

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: 10/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/25/2021
• Supplement Dates Manufacturer Received: 11/25/2021; 02/14/2022
• Supplement Dates FDA Received: 12/22/2021; 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2008
• 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