BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
Model Number M00545170 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/23/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an autotome rx 44 was intended to be used in the common bile duct in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, upon receipt of the device from the delivery, it was noticed that the package of the device was completely ripped open, exposing the device completely.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|