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  

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 forceps elevator of the subject device.The subject device had been returned from the user because the forceps elevator wire of the subject device was completely broken.The occurrence date of the event is unknown, but the aware date of above malfunction is (b)(6), 2021.There was no patient injury associated with this report.

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 there was the foreign object on the forceps elevator of the subject device.Omsc reviewed the evaluation report of olympus (b)(4).Omsc found the new reportable malfunction which there was a sign of insufficient or incorrect reprocessing 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.

Manufacturer Narrative

This supplemental report is being submitted to provide corrected information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root cause of the reported phenomena could not be specified however while it was reviewed the record of the former similar case, omsc presumed there was the possibility these phenomena were attributed to the following causes; -the reprocessing staff at the user facility reprocessed the device by different method from the instructions for safe use (ifu) recommendation.-the staff at the user facility was less trained on reprocessing and/or device handling according to the instructions for safe use (ifu).[notes] the instructions for safe use (ifu/ reprocessing manual) says about brushing method around the elevator at ¿3.5 manual cleaning: brushing around the forceps elevator and instrument channel outlet ¿.The instructions for safe use (ifu/ reprocessing manual) says as below: ¿3.3 precleaning: if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.¿ from the above findings, both reported phenomena could be prevented.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: 12654761
• MDR Text Key: 281270365
• Report Number: 8010047-2021-13317
• 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: 12/08/2021

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-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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