|
Model Number FLT-112S |
Device Problems
Material Rupture (1546); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/19/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Lot and serial number of the device not provided by the complainant, therefore the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
|
|
Event Description
|
It was reported that on november 19th , during a resection procedure while using the fluent system , the tissue trap of the fluent disposable started bubbling and then detached and leaked, causing the surgery to be stopped.Afterwards the doctor aborted fluent use and asked for a standard resectoscope to complete case.No patient injury reported.No additional information available.
|
|
Search Alerts/Recalls
|
|
|