BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
Model Number M00545200 |
Device Problem
Failure to Align (2522)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/21/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an autotome¿ rx 39 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was difficult to bow the autotome.When the physician was finally able to bow the autotome, the device stayed in the bowed position.The procedure was completed with another autotome¿ rx 39.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.
|
|
Manufacturer Narrative
|
A visual evaluation of the returned device found that the working length was twisted and the cutting wire was kinked.The exposed cutting wire length was within specification.Functional inspection was performed.The unit was tested inside and outside the duodenoscope, and the unit was able to bow and release the bow within specification.The condition of the returned unit was not consistent with the complaint incident that the tip of the tome failed to unbow.The complaint was not confirmed.Therefore, the most probable cause is operational context, since anatomical and/or procedural factors encountered during procedure could have affected the device performance.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
|
|
Event Description
|
It was reported to boston scientific corporation that an autotome rx 39 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was difficult to bowthe autotome.When the physician was finally able to bow the autotome, the device stayed in the bowed position.The procedure was completed with another autotome rx 39.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
|
|
|