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

Model Number	GIF-XP150N
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
The customer reported to olympus that when using a gastrointestinal videoscope, there were air/water flow issues from the air/water system.The problem was identified on inspection for use.The intended procedure was completed.The intended procedure is unknown.There was no patient harm associated with the event.The device was returned and evaluated, and upon estimation, there was foreign matter found clogging the nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated and the customer¿s allegation was confirmed due to foreign material clogging the nozzle.Additional evaluation findings were as follows: the water supply volume and the water removal ability did not meet the standard value, the bending section cover had a pinhole and a scratch, the adhesive on the bending section cover had a chip, the suction cylinder was shaved, switch 1 had a scratch, and the connecting tube had a scratch, a dent, coating peeling and a wrinkle.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.The following information was obtained on follow up with the customer: the device was cleaned, disinfected and sterilized before it was returned to olympus.The customer was not able to provide additional information regarding the foreign material found adhered to the scope.There was no delay in the start of pre-cleaning.The air/water nozzle was flushed with water and air.There were no abnormalities in the accessories used for reprocessing of the scope.The air/water nozzle was not wiped/brushed with cloths, brushes or sponges.The air/water nozzle was flushed with detergent solution.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 root cause could not be determined.It was confirmed that the nozzle was clogged with foreign material, however, the specific material could not be identified.The nozzle was not deformed so it is likely the material remained in the device due to a deviation in reprocessing from the instructions for use (ifu).It was confirmed that reprocessing failed to be performed according to the ifu.The event can be detected by following the ifu which state: "[inspection of the endoscope].Inspect the air/water nozzle at the distal end of the endoscope¿s insertion tube for abnormal swelling, bulges, dents or other irregularities.[inspection of the objective lens cleaning function].Inspection of the water feeding function.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: 16792696
• Report Number: 9610595-2023-06553
• Device Sequence Number: 17568968
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 03/23/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/22/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2008
• 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