|
Model Number M00535150 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/11/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that a stonetome was used in the bile duct during a common bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was advanced to the papilla.Upon trying to perform papillary incision, the pull wire from the handle separated.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
The problem code 1069 captures the reportable event of cutting wire broken.Visual examination of the returned device revealed that the cutting wire was broken and melted (blackened) in the distal section.It was reported that the cutting wire broke at the handle section.Analysis of the returned device confirmed the reported complaint of cutting wire broken; however, the break was found near the distal section.It is most likely that manipulation of the device or interaction with the endoscope or with other devices could have caused the failures noted.Therefore, the most probable cause of this complaint is adverse event related to procedure, since it is most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
|
|
Event Description
|
It was reported to boston scientific corporation that a stonetome was used in the bile duct during a common bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was advanced to the papilla.Upon trying to perform papillary incision, the pull wire from the handle separated.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|