BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068505110 |
Device Problem
Torn Material (3024)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Mfg.Site name - (b)(4) medical.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 an obtryx ii system was used during an unknown procedure and date.According to the complainant, during procedure, the physician passed the right introducer through the obturator muscle and attached the mesh.When he pulled out the mesh to pass through the muscle, the mesh broke apart.There were no breakage noticed along the suture length.The procedure was completed with another obtryx ii 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 not in danger.
|
|
Search Alerts/Recalls
|
|
|