Model Number GWH3505R |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
|
|
Event Description
|
It is reported during an unspecified procedure using a 0.035" hybrid wire, the device was torn when pulled out of the patient (broke outside of the patient).There was no patient impact related to this occurrence.
|
|
Manufacturer Narrative
|
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive cause of the reported events could not be established.
|
|
Search Alerts/Recalls
|