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 11/28/2016 |
Event Type
malfunction
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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.(b)(4).The device has not been received for analysis.Upon receipt and 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 uphold¿ lite was used during an anterior repair procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached and was able to retrieved inside the capio cage.The procedure was completed with another uphold¿ lite 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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A visual examination of the returned uphold¿ lite revealed that the lead suture broke.The analysis reveals that the suture on the blue dilator was broken and the dart was missing and not returned.Analysis reveals that the cage on the capio slim is damaged.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.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite was used during an anterior repair procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached and was able to retrieved inside the capio cage.The procedure was completed with another uphold¿ lite 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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Search Alerts/Recalls
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