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Model Number M0068505110 |
Device Problems
Material Fragmentation (1261); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/06/2014 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an obtryx ii, halo was used during a mid urethral sling procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the physician improperly released the arms of the sling.The plastic sleeve tore and a portion of the sleeve remains in the patient's obturator.The procedure was completed with this device.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.
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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.However, the complainant reported that the device was not expired.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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