BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
|
Back to Search Results |
|
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 a solyx system device was used during a procedure performed on (b)(6) 2022.During the procedure, the surgeon was concerned that the solyx sling device was too stretched.However, the procedure was aborted due to the perforation in the urethra during the sling placement.Reportedly, the injury was caused by a non-bsc surgical instrument.
|
|
Search Alerts/Recalls
|
|
|