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

Model Number	JF-140R
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.It has been over 9 years since the subject device was manufactured.During inspection and testing of the returned device, service confirmed the customer¿s reported issue and found foreign material in the instrument/biopsy channel.Based on the results of the investigation, the following are the probable causes; however, a definitive root cause could not be determined: deformation of the forceps channel.Breakage of the instrument.Foreign material in the forceps channel.The event can be detected/prevented by following the instructions for use: operation manual: 3.8 inspection of the endoscopic system.Inspection of the instrument channel and forceps elevator.Operation manual: important information ¿ please read before use precautions.Operation manual: 3.6.Inspection of ancillary equipment.Operation manual: 4.3.Using endotherapy accessories.Reprocessing manual 5.Reprocessing the endoscope (and related reprocessing accessories).Reprocessing manual 7.Reprocessing endoscopes and accessories using an aer/wd.During the device evaluation, service found the distal end cap (c-cover) was cracked.The rubber adhesive in the bending section was chipped.The bending tube was deformed.The paint on the up/down knob was peeling off.Switch #1 had a cut.The up/down/right/left angulation was out of specification due to stretching of the angle wires.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer sent the subject device to an olympus service center for evaluation with a report that the forceps could not be inserted or removed.There was no patient or user injury reported.

• 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: 15925359
• Report Number: 9610595-2022-04962
• Device Sequence Number: 5054180
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: JF-140R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2013
• 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