MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that after using subject device, the subject device was brushed manually with the cleaning brush bw-400l and reprocessed with the automated endoscope preprocessor (probably oer series aer).As a result, foreign material (tubifex-like tissue) was attached to the net at the bottom of the reprocessing basin.The user stated that even though the balloon channel of the subject device had been brushed many times and the subject device had been reprocessed many times (four times), the subject foreign material was still attached to the net.When the cleaning brush was inserted into the balloon channel up to the point where it hit, and was pulled out, there was no dirt on the cleaning brush.Before the brushing, the balloon was removed, and the detergent was sucked for thirty seconds.It was surmised that the subject foreign material came out from the balloon channel of the subject device.The subject device was used for endoscopic ultra sound-guided fine needle aspiration and the user stated that there was no feeling of strangeness and/or abnormality during the procedure.The field service engineer confirmed following on-site.The user had not checked the subject device with using maj-1444 immediately after the procedure and before the procedure.Reprocessing was performed (preclean of the channels at the bedside in the procedure room immediately after the procedure with injection tube, brushing at the sink, reprocess with oer).There was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The evaluation is in progress currently.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The evaluation was completed.During device evaluation, the phenomenon was not reproduced.As there are no abnormalities as well as in appearance, we could not determine the cause of the phenomenon based on the investigation result.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The event can be prevented by following the instructions for use which state: ¿instruction manual chapter 7 cleaning, disinfection, sterilization procedure 7.3 bedside cleaning instruction manual chapter 3 preparation and inspection 3.6 inspection of combination function with related equipment inspection of air supply function.Instruction manual chapter 7 cleaning, disinfection, and sterilization procedures if the product is extremely dirty or cannot be cleaned immediately after each case.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 13281995
• MDR Text Key: 295336573
• Report Number: 8010047-2022-01567
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 06/11/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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