BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and 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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Event Description
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Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that two uphold (tm) lite with capio slim devices were used during a vault suspension procedure performed on (b)(6) 2018.According to the complainant, during the procedure, for the first device, the dart detached from the suture and it was not recovered from the patient.Subsequently, the physician opened a second device and the same issue occurred but the dart was removed from the patient.However, it is unknown how the dart was retrieved for the second device.The procedure was completed with another uphold (tm) lite with capio slim.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 okay.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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