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 02/09/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been received for analysis.Upon receipt and 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 uphold lite with capio slim was used during a vaginal mesh implant procedure on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the dart detached from the suture when it was being loaded in the capio device.The procedure was completed with another uphold lite with capio slim.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
|
|
|