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
As reported, during reprocessing it is found that there is no air/water (a/w) flow from scope.There was no patient harm, no user injury reported due to the event.Device evaluation found nozzle is clogged with foreign material.This report is being submitted for the clogged nozzle with foreign material found during device evaluation.
Additional Manufacturer Narrative
Evaluation of the device determined that the reported air/water flow issue was confirmed.The unit¿s air/water nozzle was blocked with foreign debris and was found deformed.Due to the deformation of the nozzle, the amount of water contact does not meet the standard value.Due to deformation, the water removal ability does not pass the standards.Due to a dent on nozzle, water supply volume does not meet the standard value.Furthermore, the following findings during inspection were noted on the device: objective lens has a chip distal end has a scratch adhesive on a-rubber is detached connecting tube has a wrinkle grip has a scratch forceps channel port is shaved s-cylinder is shaved switch (sw1) has a cut universal cord has a scratch scope (s-connector) has a scratch scope case (sc cover) unit has a scratch angulation is lower than standard angulation is play due to damage on channel (ch-tube) , forceps cannot be inserted smoothly due to damage on charge-coupled device (ccd) unit, the specified resolving power is not obtained with afi mode 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 root cause of the event was unable to be identified; however, foreign fibrous matter is clogged in the nozzle.There was no nozzle deformation or damage 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: 15259662
• Report Number: 9610595-2022-01093
• Device Sequence Number: 6688071
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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: 07/24/2022
• 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: 07/24/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2013
• 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