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

Model Number GIF-Q150X

Device Problems Signal Artifact/Noise (1036); Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported to olympus, that the gastrointestinal videoscope had blurred image.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The device was returned for evaluation and the customer¿s allegation was not confirmed.It was noted that the endoscope connector had corrosion due to water leakage.The connector also had deformation to the guide pin which resulted in water tightness being lost.The device had scratches noted throughout the device.The mouthpiece was loose and the color ring had a crack.It was also noted that the paint on the control section was peeled.The control unit had discoloration and the bending section rubber had a crack/chip.The play of the up/down knob and the bending angle in the up direction did not meet standard value due to wear of the angle wire.The connecting tube had a dent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the reported problem could not be confirmed but also has not been ruled out.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Event Description

The reported phenomenon occurred during a therapeutic endoscopy procedure.There was no delay in procedure, and the procedure was completed with the same device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: 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: 16230286
• MDR Text Key: 309301072
• Report Number: 9610595-2023-01183
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q150X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CV-170, SN (B)(6)