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

Model Number GIF-Q180

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device evaluation found the reported issue was confirmed.Evaluation found water supply, air supply suction failed testing.In addition, angulation test failed.Bend angles (up, down.Right, left ) found to be out of specifications.Additionally, as stated in section b5, foreign material that cannot be removed even if the correct reprocess performed due to buckling of each channel /nozzle was identified.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer (3rd party distributor ) reported "missing water supply" (no air/water flow , reduced angulation) issue.The issue found at preparation for use.There was no patient harm, no user injury reported.Device evaluation found foreign material that cannot be removed even if the correct reprocess performed due to buckling of each channel /nozzle.This report is being submitted due to the findings of foreign material that cannot be removed even if the correct reprocess performed due to buckling of each channel /nozzle identified during device evaluation.

Event Description

The device failed not during the procedure, but before reprocessing this endoscope.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct b5.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 foreign material was identified as gauze fibers but the root cause could not be specified.The event can be detected/prevented by handling the device in accordance with the following instructions for use: ifu: evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection shows how to detect the event.Ifu: evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) shows how to prevent the event.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 17035660
• MDR Text Key: 316302870
• Report Number: 9610595-2023-08248
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170202247
• UDI-Public: 04953170202247
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2012
• 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