Model Number HX-400U-30 |
Device Problem
Difficult to Remove (1528)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
|
|
Event Description
|
During a polypectomy of a large pedunculated polyp in the sigmoid, the subject device was used.The loop was closed and could not be detached as the wires were bent in the handle.The user cut wires and loosened the loop with help of diathermy.The intended procedure was completed with large clips.The sedation and duration of the examination was extended from 30 minutes to 110 minutes.The patient had massively prolonged intravenous anaesthesia with drop in blood pressure and circulatory problems.It was reported circulatory support was needed.There was thermal damage to the intestinal wall due to needle knife with diathermy.
|
|
Manufacturer Narrative
|
This is a supplemental report to provide additional information.It was additionally reported that the examination time was extended to approximately 1 hour, but the patient's health and circulation were stable and the intended procedure was completed.The patient had no late effects.As a result, omsc concluded that the reported event was not reportable event.
|
|
Search Alerts/Recalls
|