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 07/14/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Mfg site name - freudenberg medical.The device has been received for analysis.Upon 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 a trans-obturator sling procedure performed on (b)(6) 2016.According to the complainant, the mesh was noted to be torn when it was about to be implanted.Another obtryx ii system was used to finish the procedure.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
|
Analysis of the returned obtryx ii system revealed that the mesh was returned torn into two pieces.Both pieces were stretched and torn.The blue centering tab is still attached to the mesh.Both dilators were returned with sleeves attached.Analysis revealed 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 an obtryx ii system was used during a trans-obturator sling procedure performed on (b)(6) 2016.According to the complainant, the mesh was noted to be torn when it was about to be implanted.Another obtryx ii system was used to finish the procedure.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
|
|
|