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

Model Number	TJF-145
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and the evaluation found no malfunctions aside from the allegation reported in b5.Cleaning, disinfecting, and sterilization (cds) information: the device was reprocessed according to user manual.There was no malfunction of the accessories used for reprocessing.There were no delays during the pre-cleaning phase.There were no delays during the manual cleaning phase.Aniosyme xl3 detergent was used in the manual cleaning phase.The surface of the device has been cleaned during pre-cleaning.The surface of the device was scrubbed/ brushed during the manual cleaning phase.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, the duodenovideoscope exhibited a gap in adhesive area between plastic cover and distal end and a stain inside of the light guide lens.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 18 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of "gap in adhesive area between plastic cover and distal end" was presumed to have been due to physical stress that was applied to the distal end while the user was handling the subject device.The suggested phenomenon of "inside of lg-lens [light guide lens] was stained" was confirmed, but the material could not be further identified.It was concluded that the material could not be removed via the normal reprocessing of the device.Suggested event 1- "gap in adhesive area between plastic cover and distal end": the user may be able to detect this event by handling device in accordance with the following instructions for use (ifu): inspection of the endoscope.The user may be able to reduce / prevent occurrence of this event by handling device in accordance with the following ifu: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Suggested event 2 - "inside of lg-lens [light guide lens] was stained" : the user may be able to detect this event by handling device in accordance with the following ifu: inspection of the endoscope.It is suggested that the user facility review the method of device handling according to the instructions for use (ifu).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 18792784
• Report Number: 9610595-2024-04110
• Device Sequence Number: 18082156
• Product Code: FDT
• UDI-Device Identifier: 04953170339950
• UDI-Public: 04953170339950
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: Other
• Device Model Number: TJF-145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2005
• 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