Model Number TJF-Q190V |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 05/23/2023 |
Event Type
Injury
|
Event Description
|
A company representative, on behalf of the customer, reported that an endoscope brush was stuck in the patient's biliary tract; the physician requested assistance with brush removal.Despite multiple attempts for additional information, none was obtained.
|
|
Manufacturer Narrative
|
Device information was not provided.Tjf-q190v chosen as a representative device for mdr reporting purposes.This report was submitted by the importer under the importer's report number: 2429304-2023-00271.The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a specific root cause of the brush stuck in biliary tract could not be identified from the information received.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|