BOSTON SCIENTIFIC - SPENCER TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
Model Number M00583140 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
A visual evaluation of the returned device found that the cutting wire was broken at the tip, kinked and blackened.The investigation concluded that the complaint issue of cutting wire broken was confirmed.It is most likely that a peak voltage during the procedure could cause the failures noted; therefore, the most probable root cause of this complaint is operational context due to anatomical/procedural factors encountered during the procedure.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
|
|
Event Description
|
It was reported to boston scientific corporation that a truetome¿ jag 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the cut wire broke.No part of the device detached and fell inside the patient.The procedure was completed with another truetome¿ jag 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
|
|
Search Alerts/Recalls
|
|
|