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

Model Number GIF-HQ190

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the gastrointestinal videoscope had an obstruction in the distal channel thought to be nexpowder.The issue occurred during reprocessing.There were no reports of patient harm.

Event Description

It was observed during the device inspection, that the gastrointestinal videoscope exhibited obstruction at the distal tip.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction to g3 of the initial medwatch.The aware date should be 17 march 2024.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed confirmed that a foreign object was attached to/clogged the forceps channel, but the foreign object could not be identified.It is unclear whether there was any deviation from the instruction manual in the reprocessing procedure for areas where foreign matter remained.No physical damage was observed where foreign matter remained.The detection method is described in the instruction manual gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Prevention measures are described in the instruction manual gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 19049012
• MDR Text Key: 339559538
• Report Number: 9610595-2024-07101
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: Other
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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