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

Model Number GIF-H180

Device Problem Break (1069)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus the gastrointestinal videoscope insertion tube braids or bending mesh (sharp edges) were protruding outwards.It was not specified at what point during use the event had occurred or was observed.Additionally, customer reported the following non-reportable malfunctions: device failed the leak test and during reprocessing with continuous air on, the distal tip began to swell like a balloon and caused the distal tip to rupture.There was no report of patient injury or medical intervention associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to d9, e2, e3, h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus and evaluated, and the reported sharp edges was not confirmed.Based on the results of the investigation, the root cause of the tube braids or bending mesh (sharp edges) were protruding outwards was not determined.In addition, the following non-reportable malfunctions were found during the device evaluation; air/water leakages or fluid invasion, insulation resistance value between distal end and connector is out of specification, defects of whole distal end was crack/chipping/deformation/scratch of the distal end (no shape edges), sheath perforated (exposed metal), crack of adhesive, internal rust or corrosion, image disruptions due to contact with connectors, the surface of the objective lens has poor water contact, reduced angulation.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: 18243459
• MDR Text Key: 329452992
• Report Number: 9610595-2023-18477
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339776
• UDI-Public: 04953170339776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2006
• 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