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

Model Number GIF-H180J

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The tube was found to be obstructed.The connecting tube was discolored, cut and wrinkled.The suction cover was deformed, causing water tightness to be lost, the color ring was cracked, the grip was shaved, the switch box was discolored and the switch button one (1), the control body and forceps elevator were all chipped.The air/water and suction cylinders were both discolored and the control body was dirty.The right and left knobs were scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the flushing channel on the evis exera ii gastrointestinal videoscope was ¿clogged.¿ there were no reports of patient harm associated with this event.

Event Description

The failure occurred after the procedure, during manual cleaning.The additional rinsing channel is also rinsed with tap water by means of a different hose before the scope enters the machine cleaning.It was found that rinsing was impossible.During the procedure, there was no intervention via the additional rinsing channel.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation, device history record (dhr) review and additional information regarding the event.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation determined that the brown material may have clogged the auxiliary channel when the channel was unable to be rinsed during manual cleaning after the procedure.The investigation determined there could have been multiple factors for the brown reside remaining on the device: insufficient reprocessing allowed the brown foreign material to adhere to various locations of the subject device.Pre-cleaning was not conducted immediately after procedure, which caused the adhered material to be difficult to be removed.Appropriate volume of water was not fed during pre-cleaning and/or manual cleaning, which caused the foreign material to be difficult to remove.Staff of the user facility was insufficiently trained on device handling and reprocessing in accordance with instructions for use (ifu).Instructions for use (ifu) instruct users on how to correctly reprocess scopes: reprocessing manual:precleaning the endoscope and accessories states on conduct of immediately pre-cleaning after procedure: ¿if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure.Flush the auxiliary water channel: the auxiliary water channel must be flushed either manually or using an olympus flushing pump (endoscopic flushing pump ofp or ofp-2).¿ olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II 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: 13755601
• MDR Text Key: 296979941
• Report Number: 8010047-2022-04358
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170307539
• UDI-Public: 04953170307539
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K051645
• 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: 05/27/2022

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-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• 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