MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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
It was reported by the olympus representative, the suction was clogging and the air/water supply on the gastrointestinal videoscope was poor due to insufficient or incorrect reprocessing.No patient harm reported.
Additional Manufacturer Narrative
The device was evaluated, and the reported issues were not confirmed.Water tightness was not maintained due to holes in the bending section cover caused by external factors.There was clogging in the air supply / water supply nozzle that was difficult to remove.The adhesive around the air supply / water supply nozzle was peeled off.The adhesive part of the objective lens was peeled off due to handling.The adhesive part of the lighting lens had peeled off due to handling.Image abnormalities (dive flare) were observed due to peeling of the objective lens adhesive due to external factors.Water tightness was not maintained due to wear of switch one.The bending angle was insufficient due to the elongation of the angle wire.The play of the angle knob was out of the normal state due to the extension of the angle wire.The insertion part cover was crushed due to an external factor.There were scratches on the insertion part cover, operation part, switch box, operation part cover, up/down knob, right/left knob, up/down angle fixing lever, right/left angle fixing knob universal cord, operation part side of the universal cord, scope connector, scope connector jumpsuit case due to external factors.There were wrinkles in the insertion part due to external factors.The suction cylinder was scraped due to an external factor.The paint on the suction cylinder was peeled off.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct h8.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 event occurred because of insufficient reprocessing or handling by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14286007
• Report Number: 8010047-2022-07584
• Device Sequence Number: 20397185
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• 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): 08/19/2022

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: 04/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2011
• 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