MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOACOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-LV1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gastrointestinal videoscope exhibited adhesive around objective lens had foreign objects and low angulation in all direction and bending tube discoloration.The issue was found at preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Corrected fields: b5 (whole rewrite), d8, e2, e3, g2 (user facility must be changed per company representative) and h6 (type of investigation code10 ¿ testing of actual/suspected device, investigation findings code 3233-results pending completion of investigation and investigation conclusions code 11- conclusions not yet available should have been added from the initial) additional information: h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four (4) years since the subject device was manufactured.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the "foreign material in objective lens¿ malfunctions could not be identified, nor the type of material.The event can be prevented by following the instructions for use which state: ifu states the detection method in ¿gastrointestinal videoscope,gif-lv1,colonovideoscope,cf-lv1l,cf-lv1i,operation manual chapter 3 preparation and inspection¿.Ifu states the preventive measures in ¿gastrointestinal videoscope,gif-lv1,colonovideoscope,cf-lv1l,cf-lv1i,reprocessing manual chapter 5 reprocessing the endoscope(and related reprocessing accessories)¿.The legal manufacturer reviewed the costumer provided answers for the cleaning disinfection and sterilization (cds) process where no obvious deviation form instructions for use (ifu) were identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed during the device inspection, that the gastrointestinal videoscope exhibited adhesive around objective lens had foreign objects.There were no reports of patient involvement.

• Brand Name: GASTROINTESTINAL VIDEOACOPE
• Common Device Name: GASTROINTESTINAL 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: 19029431
• Report Number: 9610595-2024-06904
• Device Sequence Number: 6985897
• Product Code: FDS
• UDI-Device Identifier: 04953170312373
• UDI-Public: 04953170312373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: GIF-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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