BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during preparation, the needle detached outside the patient.The procedure was completed with another uphold¿ lite device.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.
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Manufacturer Narrative
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Analysis of the returned device revealed that the dart is detached and was not returned.Analysis also revealed that there was no damage to the capio slim suture capturing 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.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.The review and analysis of all available information fails to indicate a root cause or probable root cause for the reported event.
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Event Description
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It was reported to boston scientific corporation that an uphold lite device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during preparation, the needle detached outside the patient.The procedure was completed with another uphold lite device.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.
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