BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/19/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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 uphold (tm) lite w/ capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the body of the mesh split into two pieces.All of the components of the device have been removed from the patient using a gloved hand.The procedure was completed with another uphold (tm) lite w/ capio slim.There was no serious injury reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Manufacturer Narrative
|
Visual and functional analysis of the returned uphold (tm) lite w/ capio slim device confirmed the event.Visual inspection of the mesh assembly revealed that there was blood residue on both sleeves and was returned in two pieces.The mesh was frayed indicating that it was torn.Only one leg and a small section of the body of the mesh were returned and the leader loops were cut.Functional examination of the capio slim suture capturing device revealed no damage.The most probable root cause classification for the reported failure is operational context.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. a search of the complaint database confirmed one similar complaint exists for the specified batch. the investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.
|
|
Event Description
|
It was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the body of the mesh split into two pieces.All of the components of the device have been removed from the patient using a gloved hand.The procedure was completed with another uphold (tm) lite w/ capio slim.There was no serious injury reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Search Alerts/Recalls
|
|
|