BOSTON SCIENTIFIC - SPENCER ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on an unknown date.According to the complainant, during unpacking, the blue dilator came off from the device.The procedure was completed with another advantage fit 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 good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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An examination of the returned advantage fit system revealed that one blue dilator was separated from the sleeve.The device showed no signs of use or mishandling.The dilator showed minimal signs of bonding in that area which most likely caused the dilator to separate from the sleeve before patient contact, during unpacking.Visual analysis revealed no damage to delivery device.There was no damage to the dilator that was attached to the second sleeve.This dilator deployed from the delivery device as intended.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is manufacturing execution error since the condition of the returned device confirms the reported event and the device shows no signs of use or mishandling.An investigation is open to address this issue.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system was used during a procedure performed on an unknown date.According to the complainant, during unpacking, the blue dilator came off from the device.The procedure was completed with another advantage fit 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 good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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