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

Model Number	GIF-XP150N
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the reported issue (reduced angulation) was confirmed.It was observed the bending angel in up/down directions was out of specification due to wear of the angulation wire.In addition, service found the objective lens was scratched, the adhesive around the light guide lens was worn, the distal end was dirty, the adhesive on the bending section cover was detached, the connecting tube was wrinkled, and the image had shadows due to damaged ccd (charge-coupled device) unit.The forceps could not be inserted smoothly, and the channel cleaning brush could not be inserted smoothly due to damaged instrument channel.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported there was play in the angulation knob and the bending angle was reduced.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, foreign material was observed in the nozzle.This report is being submitted for the malfunction found during device evaluation (foreign material in nozzle).Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information that was received from the user facility regarding the reported issue.
Event or Problem Description
Additional information was received from the user facility regarding the reported event (play in the angulation knob and reduced bending angle): the reported issue was observed during routine/ general inspection, prior to an unspecified procedure.
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 root cause of the event was unable to be identified; however, it was confirmed that foreign matter was attached to the nozzle.It was confirmed that there was no deformation of the air/water nozzle and there were no obvious deviations in reprocessing.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15514240
• Report Number: 9610595-2022-02427
• Device Sequence Number: 12242404
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2023

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: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 03/08/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/20/2023; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2018
• 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