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

Model Number GIF-EZ1500

Device Problem Device Reprocessing Problem (1091)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being supplemented to provide a correction to the previous report.H6 code '3331 - analysis of production records' should be removed.The dhr verbiage below is updated and corrected.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The rest of the previous investigation remains the same and does not change.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Device was not returned for evaluation and could not be evaluated and the customer's allegation could not be confirmed.Based on the results of the investigation, the root cause could not be determined.We presume that there was difference in recognition about the device handling and reprocessing steps between recommendations by olympus and the user facility.A review of the device history record found no deviations that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): occurrence of the event can be prevented by handling the device according to the following ifu.Ifu: gif-ez1500 reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the manual (pre)cleaning of the subject device did not comply with olympus manufacturer's specifications from reprocessing manuals.It was observed and photo-documented by the olympus representative during on-site visit.The issue was observed while shadowing the reprocessing area at the user facility.There were no reports of patient harm or involvement.

• 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: 19116519
• MDR Text Key: 340687914
• Report Number: 9610595-2024-07964
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Model Number: GIF-EZ1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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