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 06/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The complainant indicated that the device was disposed and will not 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 an uphold lite with capio slim was used during an apical prolapse with graft procedure on (b)(6) 2018.According to the complainant, during the procedure, the black capio head spun around and the suture broke inside the patient.Reportedly, the broken section of the suture with the dart was retrieved by a hand.The procedure was completed with another uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
|
|
Search Alerts/Recalls
|
|
|