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

Model Number TJF-Q180V

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 that during the annual inspection at the service department of olympus (b)(4), it was found that forceps elevator had foreign material and inside of the light guide lens was dirty.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was inspected at (b)(4).(b)(4) checked the subject device and found the reported phenomena, also found that the foreign material on the forceps elevator was caused by insufficient cleaning and the insufficient reprocessed subject device might have been used to next patient.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 additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Foreign material adhered to the forceps elevator it was confirmed that there was dirt on the light guide lens glue and the light guide lens, which might indicate the insufficient reprocessing.Therefore the causes were presumed as below: there was the possibility that the brushing method for the forceps elevator by the user differed from the brushing method for the forceps elevator recommended in the instruction manual.There was the possibility that the trainings for the facility staff that the device handling according to the instruction manual, the reprocessing when the device was returned after repair and/or the general reprocessing, were insufficient.Inside of the light guide lens was dirty it was considered that stress was applied to the distal end of the subject device because there was the dent on the c-cover.Therefore the causes were presumed as below: there was the possibility that physical stress made gap at the light guide lens glue, and dirt entered from the gap.There was the possibility that the components inside the light guide lens were corroded due to the moisture ingress into the subject device, consequently corrosion product was left 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: 13065578
• MDR Text Key: 284694203
• Report Number: 8010047-2021-16670
• 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: 03/10/2022

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-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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