MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. PJF-160 RENTAL (DMY); DUODENO VIDEOSCOPE

Model Number	PJF-160
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An endoscopy support specialist (ess) visited the site to answer questions the customer had.The customer noted the duodenoscope was being reprocessed in the oer-elite since they did not want the scopes to leave the department.The scope was rarely used and was primarily being reprocessed due to the expiration of their hang time.The ess indicated the duodenoscope was not compatible with the oer-elite and needed to be taken to the sterile processing department for eto or reprocessed using an oer-pro per the instruction for use.The ess the customer that the scope was not compatible when scanned with the oer-elite.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported the duodenoscope was incorrectly reprocessed.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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 root cause of the improper reprocessing was a different procedure than what olympus recommended in device handling and reprocessing steps.Olympus will continue to monitor field performance for this device.

• Brand Name: PJF-160 RENTAL (DMY)
• Common Device Name: DUODENO VIDEOSCOPE
• 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: 17334109
• Report Number: 9610595-2023-10199
• Device Sequence Number: 20452352
• Product Code: FDT
• UDI-Device Identifier: 04953170433498
• UDI-Public: 04953170433498
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2023

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: PJF-160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2007
• 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