MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS DUODENOVIDEOSCOPE

Model Number	JF-140R
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cap was not returned for evaluation with the scope.Therefore, the cracked cap could not be confirmed.In addition to the findings reported in the event section, the bending section cover adhesive was detached, scratches were found on the device, there was a dent on the grip, the image guide protector was cut, the angle was low and the forceps knob rotated concurrently due to the right/left knob being deformed.A clogged nozzle caused the water removal ability to not meet specification.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Event or Problem Description
The customer reported to olympus, the distal end cap had a cut.The customer confirmed that there was a crack found on the cap during reprocessing.There was no tissue, blood or anything from the patient¿s body was found on the cracked distal end cap before or during reprocessing.After reprocessing, the device was only washed.During inspection and testing of the returned device, the forceps elevator was found to have foreign material, which has been attributed to inadequate cleaning.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer confirmed that the reprocessing technician cleans the dirt deposited on the devices as per the method listed on instructions for use and in this case, the foreign material was unable to be removed completely during a reprocessing method.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the foreign material was unable to be identified and the root cause was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16212392
• Report Number: 9610595-2023-01025
• Device Sequence Number: 19871730
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K980465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: JF-140R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown