• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18243459
MDR Text Key329452992
Report Number9610595-2023-18477
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170339776
UDI-Public04953170339776
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100584
Number of Events Reported1
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 NumberGIF-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 Received11/30/2023
Supplement Dates Manufacturer Received12/13/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-