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

Model Number GF-UCT180

Device Problem Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the probe of the body of the scope was found with a chip and stain on it.The ultrasound image contained two broken echo signals.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.

Event Description

A user facility reported that during pre-cleaning of the scope, a black residue was observed coming off the scope.The scope was sent for investigation and no problems were found with the scope.The scope was returned to the customer and precleaned.The black residue was observed coming off the distal end of the scope once again.The device was not used on a patient.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: "if the endoscope is not immediately pre-cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the residues are unlikely to be parts or components used for this product.Therefore, there is a high possibility that the residues coming off the product were the objects which were invaded from the outside and adhered.Correction: olympus became aware of the reported issue on october 1, 2020.

• Brand Name: EVIS EXERA II 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: 10710875
• MDR Text Key: 219547468
• Report Number: 8010047-2020-07948
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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