BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/06/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device component code is related to device problem code for the problem of needle detachment.The complaint device is not expected to be returned for evaluation; therefore, a failure 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 a uphold (tm) lite w/ capio slim was used during anterior apical support procedure on (b)(6) 2018.According to the complainant, during procedure, the dart detached from the suture during deployment of the device.Reportedly, the dart was found in the capio head.The procedure was completed with a different device.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 stable.
|
|
Search Alerts/Recalls
|
|
|