BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
|
Back to Search Results |
|
Model Number M0068507000 |
Device Problem
Bent (1059)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/29/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.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 solyx sis system was used during a sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the shaft tip bent when the physician tried to deploy the sling.The procedure was completed with another solyx sis system.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
|
|
|