|
Model Number M0063905000 |
Device Problems
Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The returned dakota basket was analyzed, and a visual inspection noted that the grasper was in a closed position when received.The sheath was found kinked/bent.The sheath was torn/split at the distal section near the tip and residues of adhesive were found.Functional inspection found the grasper was not able to open due to the torn sheath.The reported event was confirmed.Based on all available information, it is likely that handling and manipulation of the device during its use could have contributed to the encountered issues.The kinks on the sheath can cause friction between the components at the kinked areas.The force applied to the handle in order to open and close the grasper or during its actuation can lead the sheath being torn and these can cause the grasper failure in opening and closing.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
|
|
Event Description
|
It was reported to boston scientific corporation that a dakota basket was used during a procedure performed on an unknown date.During preparation, the basket failed to open.The procedure was completed with another dakota basket.There were no patient complications as a result of this event.Investigation results revealed that the sheath was torn at the distal end; therefore, this is now an mdr reportable event.
|
|
Search Alerts/Recalls
|
|
|