BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068504001 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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.The complainant indicated that the device 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 obtryx curved system device was used during a robotic sacrocolpopexy with sling mesh procedure performed on an unknown date.According to the complainant, during the procedure, the physician reported difficulty cutting the blue centering tab resulting in the mesh being placed too loosely.The procedure was completed with this device.The patient did experience stress urinary incontinence following the procedure, however no serious adverse events were reported as a result of the placement issue.All other information is unknown.Should additional relevant details become available a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|