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

Model Number	JF-140R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.During inspection and testing of the returned device, service could not reproduce or confirm the customer¿s reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, the following are the potential causes: the event occurred due to deformation of the forceps channel; the event occurred due to breakage of the instrument; the event occurred due to foreign material in the forceps channel.The event can be detected/prevented by following the instructions for use: operation manual: inspection of the endoscopic system; inspection of the instrument channel and forceps elevator.Operation manual: important information ¿ please read before use: precautions: operation manual: inspection of ancillary equipment.Operation manual: using endotherapy accessories: reprocessing manual: reprocessing the endoscope (and related reprocessing accessories).Reprocessing manual: reprocessing endoscopes and accessories using an aer/wd.During the device evaluation, service found part of the insertion tube was caught and pinched.Per the legal manufacturer, this issue identified by service has no potential to cause or contribute to death or serious injury if the malfunction were to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that the clamp was abnormal, and the lower attachment does not go down inside the patient [forceps cannot be inserted or removed].There was no patient or user injury reported.The subject device was returned to an olympus service center for evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16515490
• Report Number: 9610595-2023-04040
• Device Sequence Number: 17697486
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 12/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2004
• 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