MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-1TH190

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The customer originally returned his olympus evis exera iii gastrointestinal videoscope due to foreign material/stain adhering to the operation area.No contact information was provided to perform follow up due diligence.However, there was no patient harm or consequence reported as a result of this event.During the device evaluation, it was discovered that insufficient reprocessing was performed on the subject device as foreign material was found blocking the work channel.This report is being submitted to capture the insufficient reprocessing noted during the device evaluation.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, as noted in describe event or problem, the subject device had undergone insufficient reprocessing as foreign material was lodged at the j-tube.Consequently, the clog was present adequate water supply.Additionally, the control knob was scratched.The grip was shaved.The switch box and case were both dented.The connecting tube had coating peeling away and a cut present.The cover was also found chipped.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

Corrected fields: (medical device problem code).This report is being submitted to accurately reflect the device problem reported by the end user, and to capture additional information about the reported event.This report is also being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported device problem.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported product problem was not established.However, it was probable that the issue occurred because of the following: (a) precleaning was not performed immediately after the procedure.This would have made the removal of foreign material difficult, (b) the auxiliary channel was insufficiently reprocessed.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: "if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Flush detergent solution and air into the auxiliary water channel (for endoscopes with auxiliary water feeding only).Nothing other than sterile water should be used for auxiliary water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and/or infection." 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14602066
• MDR Text Key: 301119573
• Report Number: 8010047-2022-09472
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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