BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
|
Back to Search Results |
|
Model Number M0068507000 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.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 a solyx sis system was used during the mid urethral sling procedure on (b)(6) 2017.According to the complainant, during the procedure, the mesh carrier would not release from the shaft tip.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.
|
|
Manufacturer Narrative
|
A visual examination of the returned solyx sis system revealed that both carriers fit on and released from the delivery device.The delivery device functions as intended.No damage to the delivery device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
|
|
Event Description
|
It was reported to boston scientific corporation that a solyx sis system was used during the mid urethral sling procedure on (b)(6) 2017.According to the complainant, during the procedure, the mesh carrier would not release from the shaft tip.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
|
|
|