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

Model Number	GIF-XP150N
Medical Device Problem Codes	Device Reprocessing Problem (1091); 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
During an asset return inspection with no complaint received from the customer, clogged nozzle was observed.Foreign material was found inside the nozzle.There is no patient involvement associated on this reported event.No harm was reported.No user injury reported due to the event.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation found clogged nozzle.Foreign material was found inside the nozzle.Irrigation error occurred due to being clogged.This condition was attributed to insufficient cleaning, handling problems.Furthermore, the following defects were identified during device inspection: angulation failed specifications.Angle wire found stretched.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Adhesive around objective lens found dirty.Adhesive on a-rubber (insertion section) has white-clouded area.Adhesive on a-rubber (adhesive connection ) has a chip.Connecting tube has a buckling.Connecting tube has coating peeling.Due to the nature of this reportable event (clogged nozzle with foreign material), a follow up communication with the customer regarding the cleaning sterilization and disinfection (cds) processes was performed, however , the user facility did not provide any information.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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.Based on the results of the investigation, the identity and definitive root cause of the foreign material could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿[inspection of the endoscope] 9.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, dents, deformation, or other irregularities.[inspection of the objective lens cleaning function] inspection of the water feeding function 1.Keep the air/water valve¿s hole covered with your finger and depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens.¿ olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• 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: 16465046
• Report Number: 9610595-2023-03545
• Device Sequence Number: 17409304
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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): 04/10/2023

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: GIF-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2008
• 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