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 Known Impact Or Consequence To Patient (2692)
|
Event Date 12/15/2017 |
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 was used during a cystocele treatment procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the surgeon used the capio device to introduce the first arm of the uphold lite mesh.When the needle was tried to be inserted into the device, the capio carrier broke and fell off the device, outside the patient.The procedure was completed with another uphold¿ lite.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
|
|
|